Zimmer Biomet recalls hip replacement cups due to potential adverse tissue reactions from untested sterilant. Affected units include specific model and all lots.
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 cause tissue reactions due to untested sterilant. This could lead to health issues for users. Affected units include specific model numbers and all production lots.
The hip cup component was sterilized with hydrogen peroxide, but the residual sterilant wasn't tested for biocompatibility. This could cause adverse tissue reactions, such as inflammation or other health issues.
People with Zimmer Biomet hip replacement cups (model ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene) are affected. Those who have had the surgery and use the recalled cups are at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 26 mm, and lot number 00-8065-644-26. All production lots are affected.
Identify if your hip cup matches the model and lot number described in the recall.
The recall states there's a potential for adverse tissue reactions, but it cannot rule out the possibility. The exact risk level isn't specified.
Check if your cup is labeled 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 26 mm, and lot number 00-8065-644-26. All lots are affected.
The recall does not provide specific action steps. You should check the product details to confirm if it's affected and contact Zimmer Biomet for further 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-0361-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0361-2021 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.
