Zimmer Biomet recalls specific hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units include all lots of model 00-8065-950-32.
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Zimmer Biomet is recalling a specific hip replacement cup model due to potential adverse tissue reactions from residual sterilant. This could affect patients who received this component during surgery.
The hip cup was sterilized using hydrogen peroxide, but the residual sterilant was not tested for biocompatibility. This could potentially cause adverse tissue reactions in the body.
Patients who received this hip cup during surgery are likely affected. Those with the specific model number 00-8065-950-32 are at risk.
Check if your hip replacement cup has the model number 00-8065-950-32. This specific cup was sold as part of Zimmer Biomet's hip replacement system.
Look for the model number 00-8065-950-32 on your hip cup.
The recall states there is a potential for adverse tissue reactions, but it cannot rule out the possibility. This means the risk is not confirmed but needs attention.
Check if your hip cup has the model number 00-8065-950-32. This specific cup was sold as part of Zimmer Biomet's hip replacement system.
The recall does not specify a remedy, so you should contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0393-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0393-2021 from Zimmer Biomet. 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.