Biomet recalls A.L.P.S. Proximal Humerus Plate (11-hole, 190mm) due to incomplete design history files before distribution. Affected units sold before Dec 31, 2026.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific type of bone plate for temporary fracture fixation. The recall happens because the product was distributed without completing required design history files, which could affect safety during medical use.
The product was distributed without completing necessary design history files, which are required to ensure safety and proper function. This could lead to improper fixation or complications during healing.
Orthopedic surgeons and medical facilities that used this plate for fracture treatment. Patients receiving the plate during surgery are at risk if the design files were incomplete.
Check for the product name 'A.L.P.S. Proximal Humerus Plate (11-hole, 190mm)' with item number 110030108. Units sold before December 31, 2026 are affected.
Identify the product name and item number to confirm if it matches the recalled version.
The product was distributed without completing required design history files, which are necessary for ensuring safety during medical use.
Check for the product name 'A.L.P.S. Proximal Humerus Plate (11-hole, 190mm)' with item number 110030108 and units sold before December 31, 2026.
The recall record does not specify a remedy, so 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-2315-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2315-2020 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.
