Biomet recalls a proximal humerus plate template due to incomplete design history files. This may affect surgical implants used in fracture repair. Affected units were distributed without proper documentation.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific proximal humerus plate template used in fracture repairs because it was distributed without completing required design documentation. This could lead to safety issues during surgical procedures if the device is used without proper validation.
The device was distributed without completing the necessary design history files or transfer activities. This means the product may not have been properly validated for safety and effectiveness before being used in surgeries. Incomplete documentation could lead to potential risks during the procedure.
Surgical teams using this specific plate template for fracture repairs are likely affected. Patients undergoing the procedure with this device may be at risk if the design documentation was incomplete.
Check for the item number 110025473 on the plate template. The product was used for temporary fracture stabilization and sold with specific lot numbers: 452448 and 462794.
Look for the item number 110025473 on the plate template to confirm if it is affected.
The product was distributed without completing the required design history files or design transfer activities.
The official recall notice does not specify a remedy or action for affected products.
The recall indicates incomplete design documentation, but the official notice does not describe specific injury risks.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2314-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2314-2020 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.
