Zimmer Biomet recalls custom shoulder replacement products due to elevated bacterial endotoxin levels from cleaning issues. Affected items include specific model numbers. Consumers should contact the company for details.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Zimmer Biomet is recalling custom shoulder replacement products because cleaning issues left harmful bacterial endotoxins on the devices. This could lead to infections or other complications if the products are used without proper cleaning.
The devices contain elevated levels of bacterial endotoxins and residual debris because of a cleaning issue. This can lead to infections or other complications if the products are used without proper cleaning.
People who have received custom shoulder replacement products from Zimmer Biomet with the listed model numbers are affected. Patients undergoing surgery with these products are at the highest risk.
Check the product label for model numbers PM0000097, PM555140, PM555147, PM555319, PM555418, 113867, or 113865, or 113863. These products were sold as custom shoulder replacements.
Reach out to Zimmer Biomet directly to confirm if your product is affected and get instructions for next steps.
The recall is due to elevated levels of bacterial endotoxin and residual debris remaining on the devices from a cleaning issue.
Contact Zimmer Biomet to check if your product is affected and get instructions for next steps.
The cleaning issue could lead to infections or other complications if the products are used without proper cleaning.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0533-2020 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0533-2020 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.
