Reported Mar 4, 2015 · Terminated

CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of…

Zimmer GmbH

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 Gmbh · Sulzer Allee 8 · Winterthur, N/A · N/A

Is this the product you have?

  • CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
Lot codes and dates
  • Item numbers

    77 of 77 codes

    • 01.01012.384
    • 01.01012.385
    • 01.01012.386
    • 01.01012.387
    • 01.01012.388
    • 01.01012.444
    • 01.01012.445
    • 01.01012.446
    • 01.01012.447
    • 01.01012.448 Lot #'s: 2551762
    • 2542690
    • 2542691
    • 2543993
    • 2544892
    • 2544893
    • 2551930
    • 2551931
    • 2557054
    • 2558475
    • 2559787
    • 2563363
    • 2564657
    • 2568082
    • 2539887
    • 2540911
    • 2544894
    • 2544895
    • 2545830
    • 2545831
    • 2545832
    • 2545833
    • 2547043
    • 2547807
    • 2548952
    • 2551330
    • 2551860
    • 2551861
    • 2554798
    • 2554799
    • 2554800
    • 2558476
    • 2558477
    • 2559788
    • 2561617
    • 2562662
    • 2563364
    • 2563385
    • 2565407
    • 2566564
    • 2567294
    • 2542692
    • 2542693
    • 2544896
    • 2547044
    • 2548953
    • 2551932
    • 2553210
    • 2556029
    • 2559603
    • 2563386
Amount recalled
1908

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

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 Sep 23, 2015 · Data as of Sep 19, 6:49 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.