NexGen Option Stemmed Tibial Component recall
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
Why was NexGen Option Stemmed Tibial Component 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Unexpired Lots
- Product
- NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
- Recalling firm
- Zimmer, Inc.
- Quantity
- 2092
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- December 21, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)