Reported Jul 9, 2014 · Terminated

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part…

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. · 1800 W Center St · Warsaw, IN · 46580-2304

Is this the product you have?

  • NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Lot codes and dates
  • Size 5
  • includes the following Lot numbers

    96 of 96 codes

    • 370318
    • 37214652
    • 61424997
    • 61442318
    • 61442319
    • 61442320
    • 61451223
    • 61454955
    • 61454956
    • 61459968
    • 61459969
    • 61459970
    • 61475130
    • 61475131
    • 61475132
    • 61488234
    • 61518182
    • 61518183
    • 61518184
    • 61526402
    • 61543977
    • 61567344
    • 61567345
    • 61592091
    • 61592092
    • 61627258
    • 61627260
    • 61643935
    • 61643936
    • 61658884
    • 61658885
    • 61658886
    • 61774178
    • 61774179
    • 61774180
    • 61774181
    • 61774182
    • 61774183
    • 61863148
    • 61863149
    • 61863150
    • 61863151
    • 61863152
    • 61912439
    • 61934688
    • 61934689
    • 61935101
    • 61935102
    • 61979031
    • 61979032
    • 61979033
    • 62016160
    • 62016162
    • 62022559
    • 62037894
    • 62037895
    • 62051524
    • 62051525
    • 62069546
    • 62089014
Amount recalled
41,180 total

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

  • Nationwide

Why it was recalled

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 29, 2015 · Data as of Sep 19, 5:28 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.