Zimmer Biomet recalls hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units include specific model and all lots.
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 made with a specific type of polyethylene. The recall is because the sterilant used in production wasn't fully tested for safety, which could potentially cause tissue reactions.
The sterilant (hydrogen peroxide) used in the hip cup wasn't properly tested for safety after production. This could lead to tissue reactions, though the exact risk isn't confirmed.
People who have received this specific hip cup model from Zimmer Biomet are affected. Those with hip replacements using this cup are at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm' and the lot number 00-8065-642-22. All lots of this model are affected.
Identify if your hip cup matches the model and lot number described in the recall notice.
The recall states there is a potential for adverse tissue reactions, but the exact risk is not confirmed.
The recall does not specify a remedy, so you should check with Zimmer Biomet directly for guidance.
Yes, all lots of this specific hip cup model are affected.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0358-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0358-2021 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.
