Reported Nov 14, 2012 · Terminated

Wagner SL Revision Stem, uncemented Sterile

Zimmer, 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, Inc. · 345 E Main St · Warsaw, IN · 46580-2746

Is this the product you have?

  • Wagner SL Revision Stem, uncemented Sterile
Lot codes and dates
  • REF Numbers
    • 01.00101.914
    • 01.00101.915
    • 01.00101.916
    • 01.00101.917
    • 01.00101.918
    • 01.00102.217
    • 01.00102.219
    • 01.00102.221
    • 01.00102.619
    • 01.00102.620
    • 01.00102.621
    • 01.00102.622
    • 01.00103.015
    • 01.00103.017
    • 01.00103.021
    • 01.00103.025
    • 30.00.89.160
    • and 30.00.89.190
Amount recalled
87

This recall covers 40 products

The agency filed one notice per product. You are reading one of them; the other 39 are below.

27 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

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 Apr 16, 2014 · Data as of Sep 19, 6:19 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.