Zimmer Biomet recalls a hip replacement cup due to potential unconfirmed tissue reactions from residual sterilant. Affected units include specific model and all lots.
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 hip replacement cup component because sterilant used in manufacturing might cause tissue reactions. This could lead to health issues for users, so affected owners should contact the company.
The hip cup was sterilized with hydrogen peroxide, but the company didn't confirm if the leftover sterilant is safe for body tissue. This could cause tissue reactions, but the risk isn't confirmed.
People who own or use the specific hip cup model described in the recall are affected. Those with hip replacements using this component are at risk.
Check for the model number 00-8065-556-22 on the hip cup. All lots of this specific cup are affected.
Reach out to Zimmer Biomet directly for guidance on next steps.
The recall states there's a potential for tissue reactions but the risk isn't confirmed. Zimmer Biomet hasn't confirmed the danger.
Check for the model number 00-8065-556-22 on the hip cup. All lots of this specific cup are affected.
Contact Zimmer Biomet directly for guidance on next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0349-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0349-2021 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.
