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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77500

144 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 21, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Valorem Surgical LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

144 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 144

PALLAS M/MAXIMIS 5.5 mm Instrument Tap. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2873-2017
Recall number
Z-2873-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1007. Unknown Lot No.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 2 of 144

PALLAS M/MAXIMIS 50mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2874-2017
Recall number
Z-2874-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. C060-050; Known Lot No. WNV110516

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 3 of 144

PALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2875-2017
Recall number
Z-2875-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. C060-060; Known Lot No. WNV110516

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 4 of 144

PALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2876-2017
Recall number
Z-2876-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. CL060-100; Lot No. Unknown.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 5 of 144

PALLAS M/MAXIMIS Small Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2877-2017
Recall number
Z-2877-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. CL47-000; Known Lot No. NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 6 of 144

PALLAS M/MAXIMIS Large Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2878-2017
Recall number
Z-2878-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. CL60-100; Known Lot No. NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 7 of 144

PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2879-2017
Recall number
Z-2879-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. CR60-030; Lot No. Unknown.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 8 of 144

PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2880-2017
Recall number
Z-2880-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. CR60-035; Lot No. Unknown.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 9 of 144

PALLAS M/MAXIMIS MIS Poly Screw Driver B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2881-2017
Recall number
Z-2881-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. Unknown; Known Lot No. NHS160315.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 10 of 144

PALLAS M/MAXIMIS 30mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2882-2017
Recall number
Z-2882-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. M058-030; Lot No. Unknown.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 11 of 144

PALLAS M/MAXIMIS 35mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2883-2017
Recall number
Z-2883-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. M058-035; Known Lot No. WNV110428 & Unknown.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 12 of 144

PALLAS M/MAXIMIS 40mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2884-2017
Recall number
Z-2884-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. M058-040; Known Lot No. WNV120322 & Unknown.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 13 of 144

PALLAS M/MAXIMIS 45mm MIS . Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2885-2017
Recall number
Z-2885-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. M058-045; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 14 of 144

PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2886-2017
Recall number
Z-2886-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. M058-050; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 15 of 144

PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2887-2017
Recall number
Z-2887-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. M058-060; Known Lot No. WNV120322 & Unknown.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 16 of 144

PALLAS M/MAXIMIS 70mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2888-2017
Recall number
Z-2888-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. M058-070; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 17 of 144

PALLAS M/MAXIMIS 80mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2889-2017
Recall number
Z-2889-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. M058-080; Known Lot No. WNV111019 & WNV120424.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 18 of 144

PALLAS M/MAXIMIS 40mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2890-2017
Recall number
Z-2890-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. MR58-040; Known Lot No. NHS150817.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 19 of 144

PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2891-2017
Recall number
Z-2891-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. MR58-035; Known Lot No. NHS150611 & WNV120323.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 20 of 144

PALLAS M/MAXIMIS 45mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2892-2017
Recall number
Z-2892-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. MR58-045; Known Lot No. WNV110128.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 21 of 144

PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2893-2017
Recall number
Z-2893-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. MR58-050; Known Lot No. WNV101020.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 22 of 144

PALLAS M/MAXIMIS 55mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2894-2017
Recall number
Z-2894-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. MR58-055; Known Lot No. NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 23 of 144

PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2895-2017
Recall number
Z-2895-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. MR58-060; Known Lot No. NHS150611 & NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 24 of 144

PALLAS M/MAXIMIS 120mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2896-2017
Recall number
Z-2896-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. MR58-080; Known Lot No. WNV120424.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 25 of 144

PALLAS M/MAXIMIS Set Screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2897-2017
Recall number
Z-2897-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. N009-000; Known Lot No. NHS160219, NHS151030, WNV120323, WNV110427, WNV101206, WNV120320, WNV120321, NHS150813.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 26 of 144

PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2898-2017
Recall number
Z-2898-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P355-030; Known Lot No. WNV120322

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 27 of 144

PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2899-2017
Recall number
Z-2899-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P355-050; Known Lot No. WNV110513.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 28 of 144

PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2900-2017
Recall number
Z-2900-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P355-040; Known Lot No. WNV110511.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 29 of 144

PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2901-2017
Recall number
Z-2901-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P365-045; Known Lot No. WNV110513.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 30 of 144

PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2902-2017
Recall number
Z-2902-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P365-050; Known Lot No. WNV110513.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 31 of 144

PALLAS M/MAXIMIS Poly Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2903-2017
Recall number
Z-2903-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P365-055; Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 32 of 144

PALLAS M/MAXIMIS Poly Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2904-2017
Recall number
Z-2904-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P375-040; Known Lot No. WNV120328 & WNV110525.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 33 of 144

PALLAS M/MAXIMIS Poly Screw 7.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2905-2017
Recall number
Z-2905-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P375-045; Known Lot No. WNV120328.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 34 of 144

PALLAS M/MAXIMIS Poly Screw 7.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2906-2017
Recall number
Z-2906-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P375-050; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 35 of 144

PALLAS M/MAXIMIS Poly Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2907-2017
Recall number
Z-2907-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P375-055; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 36 of 144

PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2908-2017
Recall number
Z-2908-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P755-030; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 37 of 144

PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2909-2017
Recall number
Z-2909-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P755-035; Known Lot No. WNV120322 WNV120413.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 38 of 144

PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2910-2017
Recall number
Z-2910-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P755-040; Known Lot No. Unknown, WNV110513, WNV120322, WNV110511.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 39 of 144

PALLAS M/MAXIMIS Polyaxial and MIS Screw, 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2911-2017
Recall number
Z-2911-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P755-045; Known Lot No. WNV110511, WNV120413, WNV120322, WNV120427, WNV130510.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 40 of 144

PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2912-2017
Recall number
Z-2912-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P755-050; Known Lot No. WNV110513 and Unknown

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 41 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2913-2017
Recall number
Z-2913-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P765-035; Known Lot No. WNV110513, WNV120420.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 42 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2914-2017
Recall number
Z-2914-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P765-040; Known Lot No. WNV120322, WNV110512, WNV120427, WNV120413.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 43 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm and 6.5 x 4.5 screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2915-2017
Recall number
Z-2915-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P765-045; Known Lot No. Unknown, WNV120420, WNV120322, NHS150153, WNV120427, WNV120430.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 44 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2916-2017
Recall number
Z-2916-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P765-050; Known Lot No.Unknown, WNV110513, WNV120430, WNV120540, WNV120322, WNV120372.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 45 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2917-2017
Recall number
Z-2917-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P765-055; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 46 of 144

PALLAS M/MAXIMIS MIS Screw 7.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2918-2017
Recall number
Z-2918-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P775-035; Known Lot No. WNV110525.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 47 of 144

PALLAS M/MAXIMIS MIS Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2919-2017
Recall number
Z-2919-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P775-040; Known Lot No. WNV110513.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 48 of 144

PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2920-2017
Recall number
Z-2920-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P775-045; Known Lot No. Unknown, WNV120328, WNV120430, WNV110513.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 49 of 144

PALLAS M/MAXIMIS 7.5 x 50mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2921-2017
Recall number
Z-2921-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM775-050; Known Lot No. Unknown, WNV120328, WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 50 of 144

PALLAS M/MAXIMIS MIS Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2922-2017
Recall number
Z-2922-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. P775-055; Known Lot No. WNV120322, WNV120328.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 51 of 144

PALLAS M/MAXIMIS MIS Screw 5.5 x 45mm & 5.5 x 4.0mm, and 7.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2923-2017
Recall number
Z-2923-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM755-045; Known Lot No. Unknown, WNV130510, WNV120275, NHS160219, NHS170323, NHS150813.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 52 of 144

PALLAS M/MAXIMIS MIS Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2924-2017
Recall number
Z-2924-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM755-050; Known Lot No. Unknown, NHS160219, NHS150813, WNV110513, WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 53 of 144

PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2925-2017
Recall number
Z-2925-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM755-055; Known Lot No. NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 54 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2926-2017
Recall number
Z-2926-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM765-035; Known Lot No. Unknown.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 55 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2927-2017
Recall number
Z-2927-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM765-040; Known Lot No. Unknown, NHS150813, WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 56 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2928-2017
Recall number
Z-2928-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM765-045; Known Lot No. NHS160219, NHS150813, WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 57 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2929-2017
Recall number
Z-2929-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM765-050; Known Lot No. Unknown, NHS160219, WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 58 of 144

PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2930-2017
Recall number
Z-2930-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM765-055; Known Lot No. Unknown, NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 59 of 144

PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2931-2017
Recall number
Z-2931-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PS355-035; Known Lot No. WNV101201.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 60 of 144

PALLAS M/MAXIMIS Poly Screw 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2932-2017
Recall number
Z-2932-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PS355-040; Known Lot No. NHS150813, WNV101201.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 61 of 144

PALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2933-2017
Recall number
Z-2933-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PS355-055; Known Lot No. NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 62 of 144

PALLAS M/MAXIMIS Poly Screw 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2934-2017
Recall number
Z-2934-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PS355-045; Known Lot No. NHS150813, WNV101201.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 63 of 144

PALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2935-2017
Recall number
Z-2935-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PS365-035; Known Lot No. WNV101206.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 64 of 144

PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2936-2017
Recall number
Z-2936-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PS365-040; Known Lot No. NHS150813, WNV101213.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 65 of 144

PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2937-2017
Recall number
Z-2937-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PS365-045; Known Lot No. NHS150813, WNV101206.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 66 of 144

PALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2938-2017
Recall number
Z-2938-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PS365-050; Known Lot No. NHS160219, NHS101206, WNV101206.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 67 of 144

PALLAS M/MAXIMIS 30 mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2939-2017
Recall number
Z-2939-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. R060-030; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 68 of 144

PALLAS M/MAXIMIS 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2940-2017
Recall number
Z-2940-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. R060-035 and R060-040; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 69 of 144

PALLAS M/MAXIMIS MIS Screw 5.5 x 40mm and 5.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2941-2017
Recall number
Z-2941-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. PM755-040; Known Lot No. NHS150813, WNV110513, WNV12064.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 70 of 144

PALLAS M/MAXIMIS 45mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2942-2017
Recall number
Z-2942-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. R060-045; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 71 of 144

PALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2943-2017
Recall number
Z-2943-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. R060-050; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 72 of 144

PALLAS M/MAXIMIS 60mm Curved and Precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2944-2017
Recall number
Z-2944-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. R060-060; Known Lot No. WNV120323, WNV120420.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 73 of 144

PALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2945-2017
Recall number
Z-2945-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. R060-070; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 74 of 144

PALLAS M/MAXIMIS 80mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2946-2017
Recall number
Z-2946-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. R060-080; Known Lot No. WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 75 of 144

PALLAS M/MAXIMIS 35mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2947-2017
Recall number
Z-2947-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. S060-035; Known Lot No. NHS100106.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 76 of 144

PALLAS M/MAXIMIS 40mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2948-2017
Recall number
Z-2948-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. S060-040; Known Lot No. WNV101022.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 77 of 144

PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2949-2017
Recall number
Z-2949-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. S060-045; Known Lot No. WNV101015.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 78 of 144

PALLAS M/MAXIMIS 50mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2950-2017
Recall number
Z-2950-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. S060-050; Known Lot No. WNV100426.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 79 of 144

PALLAS M/MAXIMIS 60mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2951-2017
Recall number
Z-2951-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. S060-060; Known Lot No. WNV101109, WNV120322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 80 of 144

PALLAS M/MAXIMIS 70mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2952-2017
Recall number
Z-2952-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. S060-070; Known Lot No. WNV101110.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 81 of 144

PALLAS M/MAXIMIS 80mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2953-2017
Recall number
Z-2953-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. S060-080; Known Lot No. WNV100210.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 82 of 144

PALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2954-2017
Recall number
Z-2954-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. S060-250; Known Lot No. WNV111123.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 83 of 144

PALLAS M/MAXIMIS 35mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2955-2017
Recall number
Z-2955-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. SR60-035; Known Lot No. NHS100106.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 84 of 144

PALLAS M/MAXIMIS 300mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2956-2017
Recall number
Z-2956-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. SR60-300; Known Lot No. NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 85 of 144

PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2957-2017
Recall number
Z-2957-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. SR60-040; Known Lot No. WNV120328, WNV101022.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 86 of 144

PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2958-2017
Recall number
Z-2958-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. SR60-350; Known Lot No. NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 87 of 144

PALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2959-2017
Recall number
Z-2959-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. SR60-400; Known Lot No. NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 88 of 144

PALLAS M/MAXIMIS 500mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2960-2017
Recall number
Z-2960-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
2,225 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. SR60-500; Known Lot No. NHS160219.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 89 of 144

PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2961-2017
Recall number
Z-2961-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0001; Known Lot No. WNV101126.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 90 of 144

PALLAS M/MAXIMIS Tapper 5.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2962-2017
Recall number
Z-2962-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0004; Known Lot No. WNV111130.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 91 of 144

PALLAS M/MAXIMIS Tapper 6.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2963-2017
Recall number
Z-2963-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0005; Known Lot No. WNV111130.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 92 of 144

PALLAS M/MAXIMIS Wall Check. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2964-2017
Recall number
Z-2964-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0007; Known Lot No. WNV111115.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 93 of 144

PALLAS M/MAXIMIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2965-2017
Recall number
Z-2965-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0010; Known Lot No. WNV111116.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 94 of 144

PALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2966-2017
Recall number
Z-2966-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0011; Known Lot No. WNV111118, WNV120321..

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 95 of 144

PALLAS M/MAXIMIS Rod Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2967-2017
Recall number
Z-2967-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0012; Known Lot No. WNV101203, WNV111130.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 96 of 144

PALLAS M/MAXIMIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2968-2017
Recall number
Z-2968-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0014; Known Lot No. WNV110216.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 97 of 144

PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2969-2017
Recall number
Z-2969-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0015; Known Lot No. WNV111105.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 98 of 144

PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2970-2017
Recall number
Z-2970-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0016; Known Lot No. WNV100630.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 99 of 144

PALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2971-2017
Recall number
Z-2971-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0017; Known Lot No. WNV100630.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 100 of 144

PALLAS M/MAXIMIS Marking Pin (Smooth). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2972-2017
Recall number
Z-2972-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0018; no known Lot No.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 101 of 144

PALLAS M/MAXIMIS Marking Pin (Round Jaw). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2973-2017
Recall number
Z-2973-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0019; no known Lot No.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 102 of 144

PALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2974-2017
Recall number
Z-2974-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0021; Known Lot No. WNV111130.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 103 of 144

PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2975-2017
Recall number
Z-2975-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0027; Known Lot No. WNV111118.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 104 of 144

PALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2976-2017
Recall number
Z-2976-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0028; Known Lot No. WNV110406, WNV110307.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 105 of 144

PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2977-2017
Recall number
Z-2977-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0703-0030; Known Lot No. WNV111109.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 106 of 144

PALLAS M/MAXIMIS Dilator Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2978-2017
Recall number
Z-2978-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1002; Known Lot No. WNV120802.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 107 of 144

PALLAS M/MAXIMIS Dilator A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2979-2017
Recall number
Z-2979-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1003; Known Lot No. WNV111108, WNV120802, WNV111109.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 108 of 144

PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2980-2017
Recall number
Z-2980-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1004; Known Lot No. WNV120814, WNV111109.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 109 of 144

PALLAS M/MAXIMIS MIS Pedicle Cut. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2981-2017
Recall number
Z-2981-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1005; Known Lot No. WNV120320, WNV110826.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 110 of 144

PALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2982-2017
Recall number
Z-2982-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1007; Known Lot No. WNV120817, NHS170405.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 111 of 144

PALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2983-2017
Recall number
Z-2983-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1008; Known Lot No. WNV120320, WNV110830, NHS170405.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 112 of 144

PALLAS M/MAXIMIS Open Extension (Small). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2984-2017
Recall number
Z-2984-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1009; Known Lot No. WNV120820, WNV110727.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 113 of 144

PALLAS M/MAXIMIS Open Extension (Large). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2985-2017
Recall number
Z-2985-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1010; Known Lot No. WNV120820, WNV101022.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 114 of 144

PALLAS M/MAXIMIS Closed Extension. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2986-2017
Recall number
Z-2986-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1012; Known Lot No. WNV120820, WNV110821, WNV110311, WNV120914.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 115 of 144

PALLAS M/MAXIMIS Extension Block. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2987-2017
Recall number
Z-2987-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1015; Known Lot No. WNV120723, WNV110331.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 116 of 144

PALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2988-2017
Recall number
Z-2988-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1016; Known Lot No. WNV120814, WNV110322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 117 of 144

PALLAS M/MAXIMIS Extension Guide Bush. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2989-2017
Recall number
Z-2989-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1017; Known Lot No. WNV120822, WNV110318.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 118 of 144

PALLAS M/MAXIMIS Extension Sleeve. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2990-2017
Recall number
Z-2990-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1018; Known Lot No. WNV120806, WNV110322.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 119 of 144

PALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2991-2017
Recall number
Z-2991-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1019; Known Lot No. WNV120816, WNV111108.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 120 of 144

PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2992-2017
Recall number
Z-2992-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1020. Known Lot No. WNV111108, WNV120424.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 121 of 144

PALLAS M/MAXIMIS Anti Torque Device. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2993-2017
Recall number
Z-2993-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1021. Known Lot No. WNV111108, WNV120802.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 122 of 144

PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2994-2017
Recall number
Z-2994-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1023. Known Lot No. WNV111118, WNV110819, WNV110720, WNV110725, WNV120802.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 123 of 144

PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2995-2017
Recall number
Z-2995-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1025. Known Lot No. WNV120802.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 124 of 144

PALLAS M/MAXIMIS Rod Checker. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2996-2017
Recall number
Z-2996-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1026. Known Lot No. WNV100705.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 125 of 144

PALLAS M/MAXIMIS Rod Gauge. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2997-2017
Recall number
Z-2997-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1027. Known Lot No. WNV120723.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 126 of 144

PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2998-2017
Recall number
Z-2998-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1028. Known Lot No. WNV101222, WNV120802, WNV120611, WNV111109.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 127 of 144

PALLAS M/MAXIMIS MIS Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-2999-2017
Recall number
Z-2999-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1029. Known Lot No. WNV120328.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 128 of 144

PALLAS M/MAXIMIS Rod Checker and T-Bar. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3000-2017
Recall number
Z-3000-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1030. Known Lot No. WNV120802, WNV100705.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 129 of 144

PALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3001-2017
Recall number
Z-3001-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1032. Known Lot No. WNV100705, WNV120802.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 130 of 144

PALLAS M/MAXIMIS Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3002-2017
Recall number
Z-3002-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1033. Known Lot No. WNV120810, WNV111109.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 131 of 144

PALLAS M/MAXIMIS Ratchet T Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3003-2017
Recall number
Z-3003-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1036. Known Lot No. WNV111125, WNV111109, WNV120518, WNV120320.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 132 of 144

PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3004-2017
Recall number
Z-3004-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1037. Known Lot No. WNV111125, WNV120802, WNV111109.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 133 of 144

PALLAS M/MAXIMIS MIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3005-2017
Recall number
Z-3005-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1039. Known Lot No. WNV120810, WNV110520.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 134 of 144

PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3006-2017
Recall number
Z-3006-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Catalog No. 0902-1040. Known Lot No. WNV120817, WNV110830, NHS170405.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 135 of 144

PALLAS M/MAXIMIS Head Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3007-2017
Recall number
Z-3007-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. WNV110826.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 136 of 144

PALLAS M/MAXIMIS Nut Inserter B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3008-2017
Recall number
Z-3008-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. WNV110318, WNV120809.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 137 of 144

PALLAS M/MAXIMIS S. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3009-2017
Recall number
Z-3009-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. WNV111118.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 138 of 144

PALLAS M/MAXIMIS C. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3010-2017
Recall number
Z-3010-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. WNV111118.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 139 of 144

PALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3011-201
Recall number
Z-3011-201
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. NHS160315.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 140 of 144

PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3012-2017
Recall number
Z-3012-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. WNV111014.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 141 of 144

PALLAS M/MAXIMIS Persuader. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3013-2017
Recall number
Z-3013-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. NHS170410.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 142 of 144

PALLAS M/MAXIMIS Set Screw Starter. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3014-2017
Recall number
Z-3014-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. NHS170405.

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 143 of 144

PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3015-2017
Recall number
Z-3015-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. NHS160219

Distribution pattern

Nationwide Distribution - US including CA and VA.

device · product 144 of 144

PALLAS M/MAXIMIS Rod Pusher B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Z-3016-2017
Recall number
Z-3016-2017
Initiated
June 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Valorem Surgical LLC
Quantity
262 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices are not consistent with Quality System Requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices are not consistent with Quality System Requirements.

Code information

Instrument, Known Lot No. WNV11116

Distribution pattern

Nationwide Distribution - US including CA and VA.

Field note

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