The Recall Desk

FDA (Devices) recall action 66500

Zimmer, Inc. recalled 44 products on 2014-02-26

The FDA (Devices) publishes a recall like this one as 44 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 44 pages.

Products
44
Announced
2014-02-26
Critical
0
Units
309,965,920

Why these products were recalled

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These p…

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 44

  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues

    Zimmer is recalling 7 million self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30…
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    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Versa-FX II Knee Implants Due to Packaging Validation Issues

    Zimmer is recalling Versa-FX II knee implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941
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    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls 3.5 Compression Plates Due to Packaging Validation Issues

    Zimmer is recalling 3.5 compression plates sterile packaged at its Puerto Rico facility because packaging operations were not properly validated, despite passing seal integrity tests.

    Product
    3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3.5 COMP PLT, 10 HOLE
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Sterile Orthopedic Screws Due to Packaging Validation Issues

    Zimmer is recalling 7 million sterile orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28…
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    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Free-Lock Orthopedic Devices Due to Packaging Validation Issues

    Zimmer is recalling specific Free-Lock orthopedic devices because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
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    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Sterile Orthopedic Screws and Nails Due to Packaging Validation Issues

    Zimmer is recalling specific sterile orthopedic screws and nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Humeral Intramedullary Nails Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 humeral intramedullary nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Versys Femoral Stems Due to Packaging Validation Issues

    Zimmer is recalling Versys femoral stems because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS…
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    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Modular Austin Moore Femoral Neck Implants Due to Packaging Validation

    Zimmer is recalling Modular Austin Moore Femoral Neck implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls 6 Degree Femoral Heads Due to Packaging Validation Issues

    Zimmer is recalling 6 Degree COCR Femoral Heads and 6 Degree Unipolar Femoral Heads because packaging operations at a Puerto Rico facility were not properly validated.

    Product
    6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues

    Zimmer, Inc. is recalling 7,044,680 self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

    Product
    2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22…
    Category
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    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Orthopedic Implants Due to Packaging Validation Deficiencies

    Zimmer is recalling specific orthopedic implants because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
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    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls M/DN R-F IM Nails Due to Packaging Validation Issues

    Zimmer is recalling M/DN R-F IM Nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Modular Hip Cup Liners Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 modular hip cup liners because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
    Category
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    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Interlocking IM Screws and Tibial Nails Due to Packaging Validation

    Zimmer is recalling interlocking IM screws and tibial nails sterile packaged at a Puerto Rico facility because packaging operations were not properly validated.

    Product
    INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Versa-FX Orthopedic Implants Due to Packaging Validation Issues

    Zimmer is recalling specific Versa-FX orthopedic implant lots because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9 Item codes starting with…
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    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Trilogy Acet Shell and Bone Screw Medical Devices

    Zimmer is recalling Trilogy Acet Shell and Bone Screw devices due to unvalidated packaging operations at its Puerto Rico facility.

    Product
    TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TRILOGY ACET SHELL 46MM O TRILOGY ACET SHELL 48MM O TRILOGY ACET SHELL 50MM O TRILOGY ACET SHELL 52MM O TRILOGY ACET SHELL 54MM O TRILOGY…
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    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls 12/14 Femoral Heads Due to Packaging Validation Issues

    Zimmer is recalling 12/14 femoral heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
    Category
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    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Knee Implant Components Due to Packaging Validation Issues

    Zimmer is recalling specific knee implant components because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
    Category
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    0 states
  • ModerateFDA (Devices)··2014-02-26

    Zimmer Recalls Interlocking IM Screws Due to Packaging Validation Issues

    Zimmer is recalling Interlocking IM Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
    Category
    Distribution
    0 states