Reported Jan 29, 2014 · Terminated
Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
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. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
- Lot codes and dates
- Part numbers 00-5850-013-95
- Amount recalled
- 5305 distribution events
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
This product could cause temporary or reversible health problems — stop using it.
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