Reported Jun 21, 2017 · Terminated

TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M…

Zimmer Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304

Is this the product you have?

  • TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM TIBIAL I/M NAIL 15MMDX38CM TIBIAL I/M NAIL 13MMDX40CM TIBIAL I/M NAIL 14MMDX40CM TIBIAL I/M NAIL 15MMDX40CM TIBIAL I/M NAIL 13MMDX42CM TIBIAL I/M NAIL 14MMDX42CM TIBIAL I/M NAIL 15MMDX42CM TIBIAL I/M NAIL 11MMDX44CM TIBIAL I/M NAIL 13MMDX44CM TIBIAL I/M NAIL 14MMDX44CM TIBIAL I/M NAIL 11MMDX46CM TIBIAL I/M NAIL 12MMDX46CM TIBIAL I/M NAIL 13MMDX46CM
Lot codes and dates
  • Item Numbers
    • 00225326015
    • 00225328015
    • 00225330015
    • 00225332014
    • 00225332015
    • 00225334014
    • 00225334015
    • 00225336014
    • 00225336015
    • 00225338014
    • 00225338015
    • 00225340013
    • 00225340014
    • 00225340015
    • 00225342013
    • 00225342014
    • 00225342015
    • 00225344011
    • 00225344013
    • 00225344014
    • 00225346011
    • 00225346012
    • 00225346013
  • Lot Codes

    258 of 258 codes

    • 60689046
    • 60689046R
    • 60689048
    • 60689048R
    • 60541593
    • 60541593R
    • 60708943
    • 60708943R
    • 60733116
    • 60733116R
    • 60718442
    • 60738224
    • 60738224R
    • 60747428
    • 60541594
    • 60759282
    • 60759282R
    • 60729914
    • 60748950
    • 60748950R
    • 60750986
    • 60750986R
    • 60753362
    • 60753362R
    • 60837656
    • 60837656R
    • 60837650
    • 60837657
    • 60837657R
    • 60837655
    • 367894
    • 60848473
    • 367894R
    • 60848473R
    • 368331
    • 60848488
    • 60848488R
    • 368105
    • 368327
    • 368105R
    • 368327R
    • 60848481
    • 60848484
    • 60848481R
    • 60848484R
    • 60858220
    • 368330
    • 368330R
    • 368235
    • 368395
    • 60858225
    • 368235R
    • 368395R
    • 60858225R
    • 368428
    • 368433
    • 368403
    • 368415
    • 368422
    • 368442
Amount recalled
1499

This recall covers 43 products

The agency filed one notice per product. You are reading one of them; the other 42 are below.

30 more are in the archive.

Where it was sold

Why it was recalled

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 15, 2019 · Data as of Sep 19, 4:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.