Zimmer Biomet recalls hip replacement cups made with untested sterilant that may cause tissue reactions. Affected units include specific size and model numbers 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 made from crosslinked polyethylene that may have untested sterilant. This could potentially cause tissue reactions, so affected users should contact the company for details.
The sterilant used in the hip cup component wasn't tested for biocompatibility. This means there's a potential risk of tissue reactions, but it's not clear how serious the reactions would be.
People who received hip replacement cups with the specific model number 00-8065-654-28 (28mm size) are affected. Those with the cup installed in their hip joint are at most risk.
Check if your hip cup has the model number 00-8065-654-28. The cup is 28mm in size with a 10-degree inclined face and includes spacers.
Reach out to Zimmer Biomet directly for instructions on returning the affected hip cup.
The recall states there's a potential for tissue reactions, but it's not clear how serious the reactions would be. The risk is not confirmed to cause serious injury.
Check if your hip cup has the model number 00-8065-654-28. The cup is 28mm in size with a 10-degree inclined face and includes spacers.
Contact Zimmer Biomet directly for instructions on returning the affected hip cup.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0381-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0381-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
