Zimmer Biomet recalls hip replacement cups made with untested sterilant. Residual hydrogen peroxide could cause tissue reactions. Affected units: All lots of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, : 53 mm (Item 00-8065-550-28).
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 are all lots of a specific cup model.
The hip cup component was sterilized with hydrogen peroxide, but the residual sterilant wasn't tested for biocompatibility. This could lead to adverse tissue reactions if the residual hydrogen peroxide causes an immune response.
People who own or use Zimmer Biomet hip replacement cups with the specific model and item number described in the recall are affected. Those with hip replacements using this cup type are most at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 53 mm' and item number 00-8065-550-28. All lots of this specific cup are affected.
Identify if your hip cup matches the model and item number described in the recall.
The recall states that residual sterilant may cause tissue reactions, but it cannot rule out the potential for adverse reactions. The exact risk level is not specified.
The recall does not provide a specific remedy. You should check if your cup matches the model and item number described and contact Zimmer Biomet for further guidance.
Check if your hip cup is labeled as 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 53 mm' with item number 00-8065-550-28. All lots of this specific cup are affected.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0339-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0339-2021 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.
