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 or repair.
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 untested sterilant causing tissue reactions. This could lead to adverse reactions in patients needing hip surgery.
Sterilant (hydrogen peroxide) used in the cup was not tested for biocompatibility. This could cause tissue reactions if residual sterilant triggers an adverse response in the body.
Patients who received this specific hip cup model during surgery are most at risk. The recall affects all units produced with the described specifications.
Check for the model number 00-8065-646-28 on the cup. The product was sold globally with all lots affected.
Reach out to Zimmer Biomet for instructions on returning or replacing the affected hip cup.
The recall states there is a potential for adverse tissue reactions, but it cannot rule out the risk. This is a low-risk hazard.
Check for the model number 00-8065-646-28 on the cup. All lots of this specific model are affected.
The recall does not specify a stop-use instruction. Affected patients should contact Zimmer Biomet for next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0365-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0365-2021 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.
