Zimmer Biomet recalls custom ACROMI:FLANGE SET (Item PM555148) for potential bacterial endotoxin contamination during surgical use. Affected items were sold for arcomium replacement procedures.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Zimmer Biomet is recalling a custom surgical flange set (Item PM555148) because cleaning issues left bacterial endotoxins and debris on the devices. This poses a risk during surgical procedures where the devices are used for arcomium replacement.
The devices contain elevated bacterial endotoxins and residual debris due to inadequate cleaning. This can lead to infections during surgical procedures when the devices are used for arcomium replacement.
Surgical teams using the ACROMIUM FLANGE SET for arcomium replacement procedures are affected. Patients undergoing surgery with this specific device are at risk of infection.
Check for the product name 'ACROMIUM FLANGE SET' with item number PM555148. This custom surgical device is used for arcomium replacement procedures.
Reach out to Zimmer Biomet directly to confirm if your device is affected and get instructions for next steps.
The recall indicates potential bacterial endotoxin contamination, so it is not safe for use without manufacturer confirmation.
Look for the product name 'ACROMIUM FLANGE SET' with item number PM555148 used for arcomium replacement procedures.
Contact Zimmer Biomet directly to confirm if your device is affected and get instructions for next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0521-2020 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0521-2020 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.
