Zimmer recalls NexGen Stemmed Tibial Component Size 4 due to higher revision rates when used with specific LPS Flex femoral components in UK data. Affected patients should consult their surgeon about component replacement.
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 type of knee implant component because it has been linked to higher revision rates when used with certain other knee implants in UK data. This recall helps prevent unnecessary surgeries by removing the risky combination from use.
The UK National Joint Registry found that using this tibial component with certain femoral components leads to more revisions (surgery to fix the implant) than expected. This happens because the combination doesn't work as well over time in the body.
Patients who received this specific knee implant component during surgery in the UK are most at risk. The recall applies to all unexpired lots of this component.
Check if your knee implant has the model name 'NexGen Option Stemmed Tibial Component Size 4' and item number 00-5986-037-02. The recall covers all unexpired lots of this component.
Talk to your surgeon about whether this component is part of your knee implant and if a replacement is needed.
The UK National Joint Registry found higher revision rates when this tibial component is used with specific LPS Flex femoral components.
Yes, you should talk to your surgeon to determine if a replacement is needed based on your specific implant combination.
No, this recall only applies to the specific NexGen Option Stemmed Tibial Component Size 4 with item number 00-5986-037-02.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-0467-2023 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-0467-2023 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.
