Zimmer recalls NexGen Option Stemmed Tibial Component Size 3 due to higher revision rates when used with specific LPS Flex femoral components in UK National Joint Registry data.
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.
Zimmer is recalling a specific knee implant component because it has higher revision rates when paired with certain other knee implants in UK data. This means the component could need to be replaced more often than expected, potentially causing more surgery.
The recall is based on UK National Joint Registry data showing these components have higher revision rates when used together. Revision rates refer to how often the implant needs to be replaced due to failure. This combination increases the chance of needing additional surgery.
Patients who received this specific knee implant component during surgery in the UK are likely affected. Those with the NexGen Stemmed Option Tibial Component Size 3 paired with LPS Flex or LPS Flex GSF femoral components face the highest risk.
Check if your knee implant includes the NexGen Option Stemmed Tibial Component Size 3 with item number 00-5986-037-01. The recall applies to all unexpired lots of this component.
Review your surgical records or implant documentation to confirm if you have the NexGen Option Stemmed Tibial Component Size 3 with item number 00-5986-037-01.
Zimmer identified higher revision rates when this tibial component is used with specific LPS Flex femoral components in UK National Joint Registry data.
The recall does not require immediate action. Patients should check their implant details to see if they are affected by this specific combination.
This recall is about higher revision rates, not immediate safety risks like injury or death. The hazard is related to long-term implant performance.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-0466-2023 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-0466-2023 from Zimmer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
