Biomet recalls a specific proximal humerus plating system due to incomplete design history files before distribution. This may pose risks during surgical procedures. Affected patients should 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 plating system used in bone surgery. The recall is because the product was distributed without completing necessary design history files, which could lead to safety issues during surgical procedures.
The product was distributed without completing required design history files. This means the device might not meet safety standards for surgical use, potentially causing complications during bone fracture repairs.
Patients who received this specific surgical plate during procedures between 2017 and 2023 are likely affected. Surgeons and medical facilities using this model for bone fixation are at the highest risk.
Check for the product name 'A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM' with item number 110030408. The lot number 408920 was used from 2017 to 2023.
Reach out to Biomet directly for specific instructions on how to handle the recalled product.
The recall states the product was distributed without completed design history files, but does not specify if it causes harm. The official notice does not state the risk level.
Check for the product name 'A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM' with item number 110030408 and lot number 408920.
The recall 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-2323-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2323-2020 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.
