Reported Jul 9, 2014 · Terminated

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. 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 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Lot codes and dates
  • Size 3
  • includes the following Lot numbers

    231 of 231 codes

    • 370316
    • 37214039
    • 61414610
    • 61414611
    • 61442294
    • 61442295
    • 61442296
    • 61442297
    • 61450963
    • 61450964
    • 61450965
    • 61454951
    • 61454952
    • 61454953
    • 61459941
    • 61459942
    • 61475123
    • 61475124
    • 61488064
    • 61488065
    • 61488066
    • 61488067
    • 61488068
    • 61497512
    • 61497513
    • 61507223
    • 61507224
    • 61518151
    • 61518153
    • 61518154
    • 61526398
    • 61526399
    • 61558358
    • 61558359
    • 61558360
    • 61558361
    • 61567336
    • 61567337
    • 61567338
    • 61567339
    • 61592084
    • 61592085
    • 61592086
    • 61592087
    • 61627191
    • 61627192
    • 61627193
    • 61627194
    • 61627195
    • 61627196
    • 61627197
    • 61627198
    • 61627199
    • 61627201
    • 61627202
    • 61643928
    • 61643929
    • 61643930
    • 61643931
    • 61643932
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, 4:46 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.