Reported Jul 9, 2014 · Terminated

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. 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 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Lot codes and dates
  • Size 1
  • includes the following Lot numbers
    • 37217848
    • 61424993
    • 61507222
    • 61543969
    • 61774117
    • 62141262
    • 62193298
    • 62251564
    • 62261955
    • 62383353
    • 62602809
    • 62602810
    • 62602811
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, 5:30 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.