Zimmer Biomet recalls hip replacement cups made with untested sterilant. Risk of tissue reactions possible. Affected units include specific cup models sold globally. Contact for return instructions.
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 have untested sterilant. This could cause tissue reactions, though serious injury is not confirmed. Affected cups have specific measurements and were sold globally.
Sterilant (hydrogen peroxide) used in the cup was not tested for safety after sterilization. This could cause tissue reactions, but serious injury is not confirmed.
People who received this hip cup replacement during surgery are likely affected. Those with recent hip replacements are at higher risk.
Check for cup model: 28 mm diameter, 10 degree inclined face, with spacers. All lots of this specific product number (00-8065-644-28) are affected.
Zimmer Biomet will provide instructions for affected units. Check their website or contact for return details.
The recall states there is a potential for tissue reactions, but serious injury is not confirmed.
Check for cup model: 28 mm diameter, 10 degree inclined face, with spacers. All lots of product number 00-8065-644-28 are affected.
Contact Zimmer Biomet for instructions on what to do with the affected unit.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0362-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0362-2021 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.
