Biomet recalls a specific proximal humerus plating system due to incomplete design history files before distribution. This may affect surgical implants used in fracture stabilization.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific type of proximal humerus plate used in fracture surgery because it was distributed without completing required design history files. This means the product may not meet safety standards before being used in medical procedures.
The product was distributed without completing necessary design history files, which are required to ensure the device meets safety and regulatory standards before being used in medical procedures. This could potentially lead to inadequate performance or safety issues during surgery.
Surgical patients who received this specific plate model during procedures between 2020 and 2023 are likely affected. Surgeons using this model for fracture stabilization are at risk if they have not completed the required design checks.
Check if you have the Biomet A.L.P.S. Proximal Humerus Plate, High Plate Right 14 Hole 234MM with Item Number 110030409. This plate was used in surgeries between 2020 and 2023.
Verify if your plate has the Item Number 110030409 and was used in surgeries between 2020 and 2023.
The recall states the product was distributed without completing design history files, but does not specify if this causes immediate harm. The official notice does not describe a specific hazard mechanism.
Look for the Item Number 110030409 on the plate, and confirm it was used in surgeries between 2020 and 2023.
The recall does not provide a remedy or instructions to stop using the product. The official notice does not specify any action required.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2324-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2324-2020 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.
