Zimmer Biomet recalls specific hip prosthetic cups due to potential adverse tissue reactions from untested sterilant residues. Affected units include all lots of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm.
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 a specific type of hip prosthetic cup because the sterilant used in production wasn't properly tested for biocompatibility. This could potentially cause adverse tissue reactions in patients. Affected units have a unique identification number and are sold across all lots.
The hip cup was sterilized using hydrogen peroxide, but the residual sterilant wasn't tested to ensure it's safe for body tissue. This could lead to adverse reactions like inflammation or tissue damage in some patients.
Patients who have received this specific hip cup implant are likely affected. Those with the model number 00-8065-956-32 are at the highest risk.
Check if your hip cup has the model number 00-8065-956-32. This specific type of cup was sold across all production lots.
Reach out to Zimmer Biomet directly to confirm if your hip cup is affected and get instructions on next steps.
This recall specifically applies to the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 59 mm with model number 00-8065-956-32. If you have this model, contact Zimmer Biomet.
Contact Zimmer Biomet directly to confirm if your hip cup is affected and get instructions on next steps.
The recall states that the sterilant used wasn't tested for biocompatibility, which could lead to adverse tissue reactions. However, the exact risk level isn't specified in the recall notice.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0396-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0396-2021 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.
