Zimmer Biomet recalls hip replacement cups due to potential adverse tissue reactions from untested 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 hip replacement cups that may cause tissue reactions due to untested sterilant. This is serious but not immediately dangerous to all users.
The sterilant (hydrogen peroxide) used in the cup wasn't tested for biocompatibility. This could cause tissue reactions, but it's not guaranteed to cause injury.
People who received this specific hip cup model from Zimmer Biomet are affected. Those with hip replacements using this cup are at risk.
Check for the model number 00-8065-656-22 on the cup. All lots of this specific hip cup are affected.
Look for the model number 00-806:656-22 on the hip cup.
The recall states there's a potential for adverse tissue reactions, but it's not guaranteed to cause injury.
Check for the model number 00-8065-656-22 on the cup. All lots of this specific hip cup are affected.
The recall doesn't specify a remedy, so contact Zimmer Biomet 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-0383-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0383-2021 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.
