Zimmer Biomet recalls hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units include specific cup models sold globally.
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 certain hip replacement cups because the sterilant used may cause tissue reactions. This could lead to health issues for people with these implants.
The sterilant used in the hip cup component wasn't fully tested for safety. This could cause tissue reactions, but the exact risk isn't confirmed.
People with Zimmer Biomet hip cups that match the described model and lot numbers are affected. Those with the specific cup design are most at risk.
Check for the cup model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 22 mm ID, 53 mm OD with spacers. All lots of this specific item number are affected.
Identify the cup model and lot number to confirm if it's affected.
The recall states there's a potential for adverse tissue reactions but cannot confirm the risk. The exact danger level isn't specified.
The recall doesn't provide specific action steps. Check the product details to see if it's affected.
Look for the model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 22 mm ID, 53 mm OD with spacers. All lots of item number 00-8065-550-22 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-0337-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0337-2021 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.
