Biomet recalls a specific proximal humerus plating system for temporary fracture fixation due to incomplete design history files. Affected units may have safety risks during surgical use.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific type of bone plate used in hip surgery because it was distributed without completing necessary design documentation. This could pose safety risks during surgical procedures.
The product was distributed without completing required design history files or transfer activities. This means the product may not meet safety standards for surgical use, potentially causing complications during procedures.
Surgical patients who received this specific bone plate during hip surgery are affected. Surgeons and medical facilities using this product are most at risk.
Check for the product name 'A.L.P.S. Proximal Humerus Plating System 3.2mm Locking Peg 60mm' with item number 110025460. Lot number J3853404 (01)00887868134500(17)260813(10)J3853404 is also associated with this recall.
Your surgeon can confirm if you received the recalled product and provide guidance on next steps.
The product was distributed without completing required design history files or transfer activities, which may affect safety during surgical procedures.
Contact your surgeon to determine if you received the recalled product and discuss next steps.
The recall record does not mention a remedy or fix for this product.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2311-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2311-2020 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.
