Zimmer Biomet recalls hip prosthesis cups due to potential unconfirmed sterilant residue causing tissue reactions. Affected units include all lots of specific cup models.
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 all hip cup implants made with crosslinked polyethylene due to unconfirmed risks from residual sterilant. This could potentially cause tissue reactions, though the exact risk level isn't confirmed.
The hip cup implants were sterilized using hydrogen peroxide, but the company didn't confirm that the remaining sterilant is safe for body tissue. This could lead to adverse reactions like inflammation or tissue damage.
People who have received this specific hip cup implant are affected. Those with the implant are at risk of potential tissue reactions.
Check if you have a hip cup implant with the model number 00-8065-542-26. All lots of this specific cup are affected.
Look for the model number 00-8065-542-26 on your hip cup implant.
If you have a hip cup implant with model number 00-8065-542-26, you are affected.
The recall doesn't specify a remedy, so contact Zimmer Biomet directly for guidance.
The recall states potential tissue reactions but doesn't confirm the risk level or if serious injury is possible.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0325-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0325-2021 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.
