Zimmer Biomet recalls hip replacement cups due to unconfirmed risks from sterilant residue. Affected units may cause tissue reactions. 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 unconfirmed risks from sterilant residue. This could potentially cause tissue reactions in some users.
Sterilant (hydrogen peroxide) used in the hip cup was not properly tested for biocompatibility. This could mean residual sterilant might cause tissue reactions in some users.
People who received this specific hip cup model from Zimmer Biomet are affected. Those with the cup implanted in their hip are most at risk.
Check for the item number 00-8065-548-26 on the cup. All lots of this specific hip cup model are affected.
Zimmer Biomet has not provided specific return instructions in the recall notice.
The recall states there is a potential for adverse tissue reactions, but it cannot rule out the possibility. The risk is not confirmed.
Check for the item number 00-8065-548-26 on the cup. All lots of this specific hip cup model are affected.
Zimmer Biomet has not provided specific return instructions in the recall notice.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0334-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0334-2021 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.
