Zimmer Biomet recalls specific hip replacement cups due to potential adverse tissue reactions from untested sterilant residues. Affected units include all lots of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 28mm size.
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 sterilant used in manufacturing might cause tissue reactions. This could lead to health issues for people who have this implant.
The hip cup was sterilized using hydrogen peroxide, but the company didn't test if the leftover sterilant is safe for body tissue. This could cause reactions like inflammation or other health problems.
People who have received this specific hip cup implant are affected. Those with the 28mm size, crosslinked polyethylene cup with spacers are most at risk.
Check if your hip implant is labeled 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 47 mm'. All lots of this specific model are affected.
Look for the model name and size on your hip implant to confirm if it matches the recalled product.
The recall states there's a potential for adverse tissue reactions, but it cannot rule out the possibility. This means there's a risk, though not confirmed to cause serious injury.
Check if your hip implant is labeled 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 47 mm'. All lots of this specific model are affected.
The recall does not specify a remedy, so you should contact Zimmer Biomet directly to discuss next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0328-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0328-2021 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.
