Zimmer Biomet recalls certain hip replacement cups due to unconfirmed risk of 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 a specific type of hip replacement cup because the sterilant used in production may cause tissue reactions. This could lead to health issues for users, so affected individuals should contact the company for guidance.
The hip cup was sterilized with hydrogen peroxide, but the company did not confirm that the remaining sterilant is safe for body tissue. This could potentially cause tissue reactions, though the exact risk is not 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. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm' and lot number 00-8065-558-26. All lots of this model are affected.
Identify if your hip cup matches the model and lot number described in the recall.
The recall states there is a potential for tissue reactions but cannot rule out the risk. The exact danger level is not confirmed.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm' and lot number 00-8065-558-26.
The recall does not specify a remedy. Affected individuals should contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0354-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0354-2021 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.
