Zimmer Biomet recalls specific hip replacement cups due to potential tissue reactions from residual sterilant. Affected units include all lots of ZCA All Poly Acetab: 28mm, 55mm model. 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 a specific type of hip replacement cup because the sterilant used in production might cause tissue reactions. This affects all units of this model, and users should contact the company for instructions.
The hip cup was sterilized using hydrogen peroxide, but the company did not confirm that the remaining sterilant is safe for body tissue. This could potentially cause adverse reactions like inflammation or other tissue issues.
People who have received this specific hip cup model (28mm internal diameter, 55mm outer diameter) are affected. Those with hip replacements using this cup are most at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', internal diameter 28mm, and outer diameter 55mm. All lots of this specific model are affected.
Reach out to Zimmer Biomet directly for instructions on returning the affected hip cup.
The recall states that residual sterilant may cause tissue reactions, but it cannot rule out the potential for adverse reactions. The risk level is not clearly defined as high or low.
Your hip cup is affected if it has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', internal diameter 28mm, and outer diameter 55mm. All lots of this model are included in the recall.
Contact Zimmer Biomet directly for instructions on returning the affected hip cup. There is no specific deadline mentioned in the recall notice.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0343-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0343-2021 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.
