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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87661

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

Open FDA event record

Event summary

Timeline bucket
March 25, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zavation

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

71 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 71

10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.

Z-1700-2021
Recall number
Z-1700-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
56 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Product Batch: 19102741, 200127, 2001246

Distribution pattern

US nationwide distribution.

device · product 2 of 71

10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.

Z-1701-2021
Recall number
Z-1701-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
130 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

product batch: 19112827, 2002440

Distribution pattern

US nationwide distribution.

device · product 3 of 71

ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.

Z-1702-2021
Recall number
Z-1702-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
38 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Product batch: 19113036

Distribution pattern

US nationwide distribution.

device · product 4 of 71

ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.

Z-1703-2021
Recall number
Z-1703-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
335 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20071558, 19113038, 20102491, 20041108

Distribution pattern

US nationwide distribution.

device · product 5 of 71

ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures.

Z-1704-2021
Recall number
Z-1704-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
88 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

lot: 2004989, 19113039

Distribution pattern

US nationwide distribution.

device · product 6 of 71

ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.

Z-1705-2021
Recall number
Z-1705-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
14 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

lot: 20081885

Distribution pattern

US nationwide distribution.

device · product 7 of 71

ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.

Z-1706-2021
Recall number
Z-1706-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

lot: 20071860, 2004988, 19113040, 20071775

Distribution pattern

US nationwide distribution.

device · product 8 of 71

ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures.

Z-1707-2021
Recall number
Z-1707-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
2 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 19113043, 20041107

Distribution pattern

US nationwide distribution.

device · product 9 of 71

ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.

Z-1708-2021
Recall number
Z-1708-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
11 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

lot: 19113041, 20071853, 20071714, 2003803

Distribution pattern

US nationwide distribution.

device · product 10 of 71

ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.

Z-1709-2021
Recall number
Z-1709-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
72 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 2003661, 19113051, 20071709, 20071843

Distribution pattern

US nationwide distribution.

device · product 11 of 71

ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.

Z-1710-2021
Recall number
Z-1710-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
1 unit

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 19123174

Distribution pattern

US nationwide distribution.

device · product 12 of 71

ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.

Z-1711-2021
Recall number
Z-1711-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
98 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 19123263, 20061381, 20071771

Distribution pattern

US nationwide distribution.

device · product 13 of 71

ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.

Z-1712-2021
Recall number
Z-1712-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
113 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 19123264, 20071773

Distribution pattern

US nationwide distribution.

device · product 14 of 71

ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.

Z-1713-2021
Recall number
Z-1713-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
15 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 19123262, 20071774

Distribution pattern

US nationwide distribution.

device · product 15 of 71

10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in Orthopedic / spinal procedures.

Z-1714-2021
Recall number
Z-1714-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
56 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 2001246, 19102741, 200127,

Distribution pattern

US nationwide distribution.

device · product 16 of 71

10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.

Z-1715-2021
Recall number
Z-1715-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
2 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20051288

Distribution pattern

US nationwide distribution.

device · product 17 of 71

10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.

Z-1716-2021
Recall number
Z-1716-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
89 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 11285ZV, 2001200

Distribution pattern

US nationwide distribution.

device · product 18 of 71

11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.

Z-1717-2021
Recall number
Z-1717-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
7 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 2001185, 2001243

Distribution pattern

US nationwide distribution.

device · product 19 of 71

10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.

Z-1718-2021
Recall number
Z-1718-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
130 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 19112827, 2002440

Distribution pattern

US nationwide distribution.

device · product 20 of 71

11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.

Z-1719-2021
Recall number
Z-1719-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
58 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 2002437

Distribution pattern

US nationwide distribution.

device · product 21 of 71

10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.

Z-1720-2021
Recall number
Z-1720-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
122 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20051290, 20081943, 20061420, 2002439

Distribution pattern

US nationwide distribution.

device · product 22 of 71

ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.

Z-1721-2021
Recall number
Z-1721-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
72 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 2003661, 19113051, 20071709, 20071843

Distribution pattern

US nationwide distribution.

device · product 23 of 71

ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.

Z-1722-2021
Recall number
Z-1722-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
162 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20061369

Distribution pattern

US nationwide distribution.

device · product 24 of 71

ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.

Z-1723-2021
Recall number
Z-1723-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
34 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20061370

Distribution pattern

US nationwide distribution.

device · product 25 of 71

ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.

Z-1724-2021
Recall number
Z-1724-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
98 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20061381, 20071771, 19123263

Distribution pattern

US nationwide distribution.

device · product 26 of 71

ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.

Z-1725-2021
Recall number
Z-1725-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
27 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20061365

Distribution pattern

US nationwide distribution.

device · product 27 of 71

ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.

Z-1726-2021
Recall number
Z-1726-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
11 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20061366

Distribution pattern

US nationwide distribution.

device · product 28 of 71

10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.

Z-1727-2021
Recall number
Z-1727-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
24 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20061432

Distribution pattern

US nationwide distribution.

device · product 29 of 71

ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.

Z-1728-2021
Recall number
Z-1728-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
113 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 19123264, 20071773

Distribution pattern

US nationwide distribution.

device · product 30 of 71

ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.

Z-1729-2021
Recall number
Z-1729-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
15 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20071774, 19123262

Distribution pattern

US nationwide distribution.

device · product 31 of 71

10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal procedures.

Z-1730-2021
Recall number
Z-1730-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
10 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20102495

Distribution pattern

US nationwide distribution.

device · product 32 of 71

10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.

Z-1731-2021
Recall number
Z-1731-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
58 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20102486

Distribution pattern

US nationwide distribution.

device · product 33 of 71

ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.

Z-1732-2021
Recall number
Z-1732-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
22 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 20102490

Distribution pattern

US nationwide distribution.

device · product 34 of 71

10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.

Z-1733-2021
Recall number
Z-1733-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 35 of 71

10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

Z-1734-2021
Recall number
Z-1734-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 36 of 71

10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.

Z-1735-2021
Recall number
Z-1735-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 37 of 71

11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.

Z-1736-2021
Recall number
Z-1736-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 38 of 71

11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.

Z-1737-2021
Recall number
Z-1737-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 39 of 71

10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

Z-1738-2021
Recall number
Z-1738-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 40 of 71

11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

Z-1739-2021
Recall number
Z-1739-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 41 of 71

10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.

Z-1740-2021
Recall number
Z-1740-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 42 of 71

10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.

Z-1741-2021
Recall number
Z-1741-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 43 of 71

10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

Z-1742-2021
Recall number
Z-1742-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 44 of 71

10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

Z-1743-2021
Recall number
Z-1743-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 45 of 71

10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.

Z-1744-2021
Recall number
Z-1744-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 46 of 71

10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.

Z-1745-2021
Recall number
Z-1745-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 47 of 71

10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.

Z-1746-2021
Recall number
Z-1746-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 48 of 71

10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.

Z-1747-2021
Recall number
Z-1747-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 49 of 71

10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.

Z-1748-2021
Recall number
Z-1748-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 50 of 71

10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal procedures.

Z-1749-2021
Recall number
Z-1749-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Pending

Distribution pattern

US nationwide distribution.

device · product 51 of 71

CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.

Z-1750-2021
Recall number
Z-1750-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
197

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot: 2003787, 2001228

Distribution pattern

US nationwide distribution.

device · product 52 of 71

InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.

Z-1751-2021
Recall number
Z-1751-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
503 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

a) INTVM-10-DSK, lot numbers:13724ZV, 13517ZV, 13384ZV, 11658ZV, 12985ZV, 12259ZV, 11692ZV b) INTVM-10-SBK, lot numbers:12400ZV, 10784ZV, 14384ZV, 12329ZV, 11928ZV c) INTVM-15-DSK, lot numbers:12885ZV, 12108ZV, 11294ZV, 13761ZV, 11071ZV, 13908ZV, 13846ZV, 12193ZV, 11848ZV, 11624ZV, 11463ZV, 11035ZV, 10941ZV, 13410ZV, 13010ZV, 12654ZV, 12308ZV d) INTVM-15-DSKC, lot numbers:11489ZV, 11140ZV, 10904ZV e) INTVM-15-SBK, lot numbers:11219ZV, 11611ZV, 11538ZV f) INTVM-15-SIKBC, lot numbers:11725ZV, 11221ZV, 10988ZV, 10901ZV g) INTVM-20-DSK, lot numbers:11483ZV, 11250ZV h) INTVM-20-SBK, lot numbers:10954ZV, 11697ZV, 11704ZV

Distribution pattern

US nationwide distribution.

device · product 53 of 71

InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.

Z-1752-2021
Recall number
Z-1752-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
178 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

a) INTVM-15-FLDSK, Lot Numbers:10342ZV, 12525ZV, 12267ZV, 12011ZV, 10545ZV, 10048ZV, 11861ZV, 11343ZV, 11037ZV, 10780ZV, 11102ZV b) INTVM-20-FLDSK, Lot Numbers: 10312ZV, 11698ZV, 10276ZV, 10205ZV, 10031ZV

Distribution pattern

US nationwide distribution.

device · product 54 of 71

InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.

Z-1753-2021
Recall number
Z-1753-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
36 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

a) INTVMC-15-FLDSK, Lot Numbers: 10659ZV b) INTVMC-20-FLDSK, Lot Numbers: 10312ZV, 11698ZV, 10276ZV, 10205ZV, 10031ZV

Distribution pattern

US nationwide distribution.

device · product 55 of 71

InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures.

Z-1754-2021
Recall number
Z-1754-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
3 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 11613ZV

Distribution pattern

US nationwide distribution.

device · product 56 of 71

InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.

Z-1755-2021
Recall number
Z-1755-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
119 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

a) INTVMN-10-DSK, Lot Numbers: 12200ZV b) INTVMN-15-DSK, Lot Numbers: 10816ZV, 13708ZV, 13845ZV, 13522ZV, 12133ZV c) INTVMN-15-DSKC, Lot Numbers: 11843ZV, 11412ZV, 11160ZV, 11017ZV d) INTVMN-20-DSK, Lot Numbers: 14266ZV, 14238ZV, 12524ZV, 11756ZV, 11083ZV

Distribution pattern

US nationwide distribution.

device · product 57 of 71

OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.

Z-1756-2021
Recall number
Z-1756-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
200 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

a) INTV-OSFL, Lot Numbers: 11395ZV, 11285ZV, 11574ZV, 11471ZV b) INTV-OSFL-LV, Lot Numbers: 12386ZV

Distribution pattern

US nationwide distribution.

device · product 58 of 71

ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.

Z-1757-2021
Recall number
Z-1757-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
31 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 13403ZV, 14172ZV, 13723ZV, 13031ZV, 10760ZV

Distribution pattern

US nationwide distribution.

device · product 59 of 71

ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.

Z-1758-2021
Recall number
Z-1758-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
7 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 12872ZV, 12406ZV, 11934ZV

Distribution pattern

US nationwide distribution.

device · product 60 of 71

ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.

Z-1759-2021
Recall number
Z-1759-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
516 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 13378ZV, 11141ZV, 10815ZV, 13971ZV, 13921ZV, 13577ZV, 13133ZV, 13033ZV, 11793ZV, 11695ZV, 12132ZV, 14105ZV, 12280ZV, 14389ZV, 13884ZV, 11956ZV, 11470ZV, 11342ZV, 10902ZV, 10516ZV, 14358ZV, 12266ZV, 10866ZV, 10651ZV, 14207ZV, 14021ZV, 11231ZV, 11465ZV, 12025ZV, 11537ZV, 11415ZV, 10998ZV, 11072ZV, 13883ZV

Distribution pattern

US nationwide distribution.

device · product 61 of 71

ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.

Z-1760-2021
Recall number
Z-1760-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 13378ZV, 11141ZV, 10815ZV, 13971ZV, 13921ZV, 13577ZV, 13133ZV, 13033ZV, 11793ZV, 11695ZV, 12132ZV, 14105ZV, 12280ZV, 14389ZV, 13884ZV, 11956ZV, 11470ZV, 11342ZV, 10902ZV, 10516ZV, 14358ZV, 12266ZV, 10866ZV, 10651ZV, 14207ZV, 14021ZV, 11231ZV, 11465ZV, 12025ZV, 11537ZV, 11415ZV, 10998ZV, 11072ZV, 13883ZV

Distribution pattern

US nationwide distribution.

device · product 62 of 71

ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures.

Z-1761-2021
Recall number
Z-1761-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
3 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 12302ZV

Distribution pattern

US nationwide distribution.

device · product 63 of 71

ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.

Z-1762-2021
Recall number
Z-1762-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
195 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

a) VCF-1015-2, Lot Numbers: 13814ZV, 10950ZV, 11694ZV, 10953ZV, 10779ZV, 10588ZV, 13664ZV, 13469ZV, 13519ZV, 10825ZV, 13885ZV, 12989ZV, 10933ZV, 13758ZV, 14107ZV, 14206ZV, 14680ZV, 14022ZV, 11603ZV, 10505ZV b) VCF-1015-2A, Lot Numbers: 10515ZV, 14197ZV, 14114ZV, 14113ZV, 14024ZV, 14023ZV, 13641ZV, 13471ZV, 13325ZV

Distribution pattern

US nationwide distribution.

device · product 64 of 71

ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.

Z-1763-2021
Recall number
Z-1763-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
19 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 14522ZV, 12260ZV, 12896ZV, 11557ZV

Distribution pattern

US nationwide distribution.

device · product 65 of 71

ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.

Z-1764-2021
Recall number
Z-1764-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
79 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 13877ZV, 13661ZV, 13388ZV, 12897ZV, 12764ZV, 12542ZV, 14391ZV, 14287ZV, 13004ZV, 10951ZV, 14016ZV

Distribution pattern

US nationwide distribution.

device · product 66 of 71

ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.

Z-1765-2021
Recall number
Z-1765-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
302 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 13978ZV, 13966ZV, 13873ZV, 13643ZV, 13185ZV, 12594ZV, 11766ZV, 11548ZV, 11391ZV, 11139ZV, 10781ZV, 14390ZV, 13976ZV, 13711ZV, 13413ZV, 12930ZV, 12331ZV, 12300ZV, 12199ZV, 14349ZV, 11271ZV, 11847ZV, 11274ZV

Distribution pattern

US nationwide distribution.

device · product 67 of 71

ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.

Z-1766-2021
Recall number
Z-1766-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
24 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 13650ZV, 13518ZV, 11677ZV, 11678ZV, 10514ZV

Distribution pattern

US nationwide distribution.

device · product 68 of 71

ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures.

Z-1767-2021
Recall number
Z-1767-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
49 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 11958ZV, 14393ZV, 11726ZV, 11107ZV, 10955ZV

Distribution pattern

US nationwide distribution.

device · product 69 of 71

OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.

Z-1768-2021
Recall number
Z-1768-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
846 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, 13876ZV

Distribution pattern

US nationwide distribution.

device · product 70 of 71

VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.

Z-1769-2021
Recall number
Z-1769-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
140 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 10085ZV, 10086ZV, 11205ZV, 11217ZV, 11554ZV, 11558ZV, 11559ZV

Distribution pattern

US nationwide distribution.

device · product 71 of 71

VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.

Z-1770-2021
Recall number
Z-1770-2021
Initiated
March 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zavation
Quantity
35 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
may not have been adequately sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Code information

Lot Numbers: 11553ZV, 12276ZV, 9965ZV

Distribution pattern

US nationwide distribution.

Field note

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