Biomet recalls a specific proximal humerus plating system due to incomplete design history files before distribution. Affected items may pose risks during surgical use. 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 plate used in bone fracture repairs because it was distributed without completing necessary design documentation. This could affect surgical safety if the device is used without proper documentation.
The device was distributed without completing required design history files or transfer activities. This means the product may not meet safety standards for surgical use, potentially leading to complications during bone fracture repairs.
Surgical patients who received this specific plate model during procedures before December 31, 2026 are likely affected. Surgeons and medical staff using the product for bone repairs are at highest risk.
Check for the product name 'A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM' with item number 110030309. The product was sold before December 31, 2026.
Identify the specific plate model and item number to confirm if it matches the recalled product.
The recall states the device was distributed without completed design history files, but does not specify if it causes injury. The official notice does not state the hazard severity.
Check for the product name 'A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM' with item number 110030309, and ensure it was sold before December 31, 2026.
The recall does not provide specific action steps. Contact Biomet directly for guidance.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2321-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2321-2020 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.
