Biomet recalls a specific proximal humerus plating system for temporary fracture fixation due to incomplete design history files. Affected items have a unique item number and lot number. Consumers should contact Biomet for details.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific type of proximal humerus plating system used for temporary fracture fixation because it was distributed without completing required design history files. This could pose a risk to patients during surgery or healing.
The product was distributed without completing necessary design history files, which are required to ensure the device is safe and effective for medical use. This could lead to improper function or safety issues during the intended surgical procedure.
Patients who received this specific plating system for fracture treatment are most at risk. The recall applies to the exact model and lot numbers listed in the product description.
Check for the item number 110030307 and lot number 408870 on the product packaging. This specific plating system is used for temporary internal fixation of fractures.
Reach out to Biomet directly to confirm if your specific product is affected and get instructions for next steps.
The recall states the product was distributed without completing design history files, which could affect safety. Affected items should not be used until Biomet provides further instructions.
Contact Biomet directly to determine if your specific product is affected and follow their instructions.
Look for the item number 110030307 and lot number 408870 on the product packaging. Check with Biomet for confirmation.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2319-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2319-2020 from 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.
