Zimmer recalls NexGen Stemmed Tibial Component Size 8 due to higher revision rates when used with specific LPS Flex femoral components in UK joint registry data. Affected patients should consult their surgeon for alternatives.
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 some patients might need surgery more often than expected.
The recall is based on UK National Joint Registry data showing these components have higher revision rates when used together. Revision means needing additional surgery to fix the implant. This risk is specific to certain combinations of knee implants.
Patients who received this specific knee implant component during surgery in the UK are most at risk. The recall targets those who had the NexGen Stemmed Option Tibial Component Size 8 with LPS Flex or L:PS Flex GSF femoral components.
Check if your knee implant has the item number 00-5986-057-02 and size 8. The recall applies to all unexpired lots of this component.
Your surgeon can determine if your implant combination is affected and recommend next steps.
The UK National Joint Registry found higher revision rates when this tibial component is used with specific LPS Flex femoral components.
No, this is a medical device recall for patients who had surgery with this specific component. You should consult your surgeon about your implant combination.
Check for item number 00-5986-057-02 and size 8 on your implant. The recall applies to all unexpired lots.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-0471-2023 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-0471-2023 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.
