Zimmer Biomet recalls a hip replacement cup due to potential unconfirmed tissue reactions from residual sterilant. Affected units are all lots of the 28mm cup with specific ID.
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 a specific hip replacement cup model due to potential tissue reactions from residual sterilant. This could cause adverse reactions in some users, so affected owners should contact the company for details.
The hip cup was sterilized with hydrogen peroxide, but the company didn't confirm if the leftover sterilant is safe for body tissue. This could lead to tissue reactions in some users.
People who own the recalled hip cup model are affected. Those with hip replacements using this specific cup are at highest risk.
Check for the model number 00-8065-554-28 on the cup. All lots of this specific hip cup are affected.
Reach out to Zimmer Biomet for specific instructions on how to handle the recalled cup.
The recall states there's a potential for adverse tissue reactions, but it's not confirmed to cause harm in all cases.
Check for the model number 00-8065-554-28 on the cup. All lots of this specific hip cup are affected.
Contact Zimmer Biomet for specific instructions on how to handle the recalled 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-0347-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0347-2021 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.
