Reported Jul 9, 2014 · Terminated

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. 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 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Lot codes and dates
  • Size 6
  • includes the following Lot Numbers

    70 of 70 codes

    • 370319
    • 37213647
    • 37218135
    • 37218727
    • 37219556
    • 37220950
    • 61414605
    • 61414606
    • 61442322
    • 61451224
    • 61451225
    • 61451226
    • 61479488
    • 61479489
    • 61479490
    • 61518197
    • 61518198
    • 61518199
    • 61538053
    • 61543978
    • 61592093
    • 61592094
    • 61627261
    • 61643938
    • 61672569
    • 61682157
    • 61685470
    • 61721675
    • 61721676
    • 61774189
    • 61774190
    • 61774191
    • 61774195
    • 61863158
    • 61863159
    • 61863160
    • 61863161
    • 61863162
    • 61979034
    • 61979035
    • 62016163
    • 62022560
    • 62037896
    • 62041306
    • 62041308
    • 62069549
    • 62077856
    • 62141261
    • 62143609
    • 62168186
    • 62177113
    • 62227421
    • 62227422
    • 62251569
    • 62251570
    • 62261977
    • 62261978
    • 62326316
    • 62330687
    • 62341281
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, 4:50 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.