Zimmer Biomet recalls hip cups with potential adverse tissue reactions due to untested sterilant. Affected units include specific model and all lots. Contact for return instructions.
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 cups that may cause tissue reactions because the sterilant used wasn't properly tested for safety. This could lead to health issues for users.
The sterilant used in the hip cup wasn't tested to ensure it's safe for body tissues. This could cause reactions like inflammation or other health problems.
People with Zimmer Biomet hip cups (model ID 32 mm, all lots) are affected. Those with hip replacements are most at risk.
Check for the model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, ID 32 mm, Neutral, O.D. Cup with Spacers, 51 mm. All lots are affected.
Reach out to Zimmer Biomet for return instructions as the remedy is not specified in the recall.
The recall states there's a potential for adverse tissue reactions, so it's not recommended for use.
Check for the model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, ID 32 mm, Neutral, O.D. Cup with Spacers, 51 mm. All lots are affected.
Contact Zimmer Biomet for return instructions as the remedy is not specified in the recall.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0336-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0336-2021 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.
