Zimmer Biomet recalls hip replacement cups made with untested sterilant. Residual hydrogen peroxide may cause tissue reactions. Affected units: All lots of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 28mm.
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 that may have untested sterilant. This could cause tissue reactions if the residual hydrogen peroxide is not biocompatible. Affected units include all lots of the specific cup model.
The hip cup was sterilized with hydrogen peroxide, but the residual sterilant wasn't tested for biocompatibility. This could lead to tissue reactions if the residual sterilant causes an adverse reaction in the body.
People who received this hip replacement cup from Zimmer Biomet are affected. Those with the specific cup model (28mm, 10-degree inclined face) are most at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 28mm, and a 10-degree inclined face. All lots of this specific cup are affected.
Look for the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 28mm, and 10-degree inclined face on your hip cup.
The recall record does not mention any remedy or fix.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 28mm, and a 10-degree inclined face. All lots of this specific cup are affected.
The recall record does not specify any action steps for affected units.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0377-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0377-2021 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.
