Zimmer Biomet recalls hip replacement cups with unconfirmed sterilant risk. Learn if your cup is affected and what to do.
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 unconfirmed sterilant risks. This could potentially cause adverse tissue reactions, though the risk is not yet confirmed.
The hip cup component was sterilized with hydrogen peroxide, but the residual sterilant's biocompatibility wasn't confirmed. This could potentially cause adverse tissue reactions, though the risk is not yet confirmed.
People who own or use Zimmer Biomet hip replacement cups with the specific model and lot numbers mentioned in the recall are affected. Those with hip replacements are most at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetab: Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 55 mm' and lot number 00-8065-552-26. All lots of this specific model are affected.
Verify your hip cup model and lot number against the recall information provided.
The recall states that the sterilant used in the hip cup component was not evaluated for biocompatibility, which could potentially cause adverse tissue reactions. However, the risk is not yet confirmed.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 55 mm' and lot number 00-8065-552-26. All lots of this specific model are affected.
The recall does not specify a remedy, so you should check with Zimmer Biomet directly for further instructions.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0342-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0342-2021 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.
