Zimmer Biomet recalls hip replacement cups made with untested sterilant that may cause tissue reactions. Affected units include specific model and all lots. 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 contain untested sterilant, potentially causing tissue reactions. This affects patients with the specific cup model and all production lots. Immediate action is needed to prevent possible health risks.
The hip cup uses hydrogen peroxide for sterilization, but the residual sterilant wasn't tested for biocompatibility. This could cause tissue reactions if the sterilant interacts with the body.
Patients who received the recalled hip cup model are most at risk. The recall applies to all units produced with the specific model number.
Check for the model number 00-8065-558-32 on the hip cup. All production lots of this specific cup are affected.
Reach out to Zimmer Biomet for return instructions as the remedy is not specified in the recall.
The recall states there's a potential for adverse tissue reactions, but it cannot rule out the possibility. This is not confirmed to cause serious injury.
Check for the model number 00-8065-558-32 on the cup. All lots of this specific model are affected.
The recall does not specify a remedy, so contact Zimmer Biomet directly for return instructions.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0356-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0356-2021 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.
