Reported Jul 9, 2014 · Terminated

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. 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 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Lot codes and dates
  • Size 4
  • includes the following Lot numbers

    177 of 177 codes

    • 370317
    • 37214651
    • 37218726
    • 37219271
    • 37220949
    • 61417419
    • 61417420
    • 61442307
    • 61442308
    • 61442309
    • 61442310
    • 61442311
    • 61450966
    • 61451221
    • 61451222
    • 61459957
    • 61459958
    • 61475125
    • 61475126
    • 61475127
    • 61475128
    • 61488208
    • 61488209
    • 61488210
    • 61488211
    • 61518162
    • 61518163
    • 61518164
    • 61526401
    • 61538046
    • 61543975
    • 61543976
    • 61558363
    • 61567340
    • 61567341
    • 61567342
    • 61567343
    • 61592088
    • 61592089
    • 61627203
    • 61627204
    • 61627205
    • 61627206
    • 61643933
    • 61643934
    • 61658878
    • 61658879
    • 61658880
    • 61658881
    • 61658882
    • 61678232
    • 61678233
    • 61682153
    • 61682154
    • 61682155
    • 61692238
    • 61692240
    • 61721671
    • 61721672
    • 61721673
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, 6:15 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.