Zimmer Biomet recalls specific hip prosthetic cups due to potential adverse tissue reactions from untested sterilant residue. Affected units include all lots of the ZCA All Poly Acetabular Cup model.
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 hip joint cup model due to potential adverse tissue reactions from untested sterilant residue. This could cause health issues for users who have the recalled cup implanted.
The sterilant (hydrogen peroxide) used in the hip cup was not tested for biocompatibility after sterilization. This could lead to adverse tissue reactions, though the risk is not confirmed.
People who have received this hip cup implant are likely affected. Those with the specific model number and lot range are at risk.
The recalled hip cup has the model number ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm. All lots of this model are affected.
If you have a hip replacement, verify if your implant matches the recalled model and lot numbers.
The recall states there is a potential for adverse tissue reactions, but it cannot rule out the risk. The exact danger level is not specified.
The recalled cup has the model number ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 57 mm. All lots are affected.
The recall does not provide a specific remedy. You should check with your surgeon or contact Zimmer Biomet 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-0346-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0346-2021 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.
