Zimmer Biomet recalls hip prosthetic cups due to potential adverse tissue reactions from untested sterilant residues. Affected units include specific model and size.
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 joint prosthetic cups that may have untested sterilant residues. This could cause tissue reactions, but the risk is not immediate or severe for most users.
Sterilant (hydrogen peroxide) used during manufacturing wasn't fully tested for biocompatibility. This could lead to tissue reactions, but the risk is not immediate or severe for most users.
People who own or use Zimmer Biomet hip prosthetic cups with the specific model and size described in the recall are affected. Those with recent implants are at slightly higher risk.
Check for the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene' with size ID 22 mm and O.D. 45mm. All lots of this product are affected.
Reach out to Zimmer Biomet directly for guidance on next steps.
The recall states there's a potential for adverse tissue reactions, but it's not confirmed to cause serious injury. The risk is low.
Check for the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene' with size ID 22 mm and O.D. 45mm. All lots are affected.
The recall does not specify stopping use; it recommends contacting 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-0324-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0324-2021 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.
