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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65897

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

Open FDA event record

Event summary

Timeline bucket
July 31, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Spine, Inc.

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

5 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 5

PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

Z-0093-2014
Recall number
Z-0093-2014
Initiated
July 31, 2013
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
118 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

Code information

287105005

Distribution pattern

Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.

device · product 2 of 5

PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

Z-0094-2014
Recall number
Z-0094-2014
Initiated
July 31, 2013
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
105 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

Code information

287105010

Distribution pattern

Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.

device · product 3 of 5

PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

Z-0095-2014
Recall number
Z-0095-2014
Initiated
July 31, 2013
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
102 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

Code information

287105014

Distribution pattern

Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.

device · product 4 of 5

PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

Z-0096-2014
Recall number
Z-0096-2014
Initiated
July 31, 2013
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

Code information

287105018

Distribution pattern

Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.

device · product 5 of 5

PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

Z-0097-2014
Recall number
Z-0097-2014
Initiated
July 31, 2013
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
198 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

Code information

287105090

Distribution pattern

Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.

Field note

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