Zimmer Biomet recalls hip replacement cups with unconfirmed sterilant risks. Learn if your cup is affected and what to do.
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 unconfirmed sterilant risks. This could potentially cause adverse tissue reactions, though serious injury is not confirmed.
Sterilant (hydrogen peroxide) used in the cup was not tested for biocompatibility. This could lead to adverse tissue reactions, but serious injury is not confirmed.
People who received this hip cup implant during surgery are likely affected. Those with the specific cup model and size are at risk.
Check if your hip cup has the model number 00-8065-644-22 and is 22 mm in size. All lots of this specific cup are affected.
Identify if your hip cup has the model number 00-8061-644-22 and is 22 mm in size.
The recall states there is a potential for adverse tissue reactions, but serious injury is not confirmed.
Check if your hip cup has the model number 00-8065-644-22 and is 22 mm in size.
The recall does not specify a remedy, so contact Zimmer Biomet directly 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-0360-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0360-2021 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.
