Reported Dec 21, 2022 · Ongoing
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
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 Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
- Lot codes and dates
- All Unexpired Lots
- Amount recalled
- 2092
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
This product could cause temporary or reversible health problems — stop using it.
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