Biomet recalls a specific proximal humerus plate model due to incomplete design history files. Affected users should contact Biomet for details on next steps.
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 surgery. The recall is because the product was distributed without completing required design history files, which could lead to safety issues during medical procedures.
The product was distributed without completing required design history files. This could mean the device doesn't meet safety standards for medical use, potentially causing complications during surgery or healing.
Surgical patients who received this specific plate model during procedures. Medical professionals using this product for bone fixation are most at risk.
Check for the model name 'A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM' and item number 110030209. The product was sold with lot number 356280 or RM256H.
Reach out to Biomet directly for specific instructions on how to handle the recalled product.
The recall indicates the product was distributed without completing required design history files, which could pose safety risks. The official notice does not confirm if it is safe to use.
Check for the model name 'A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM' and item number 110030209. The product was sold with lot number 356280 or RM256H.
The official notice does not specify a remedy, so contact Biomet directly for instructions.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2318-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2318-2020 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.
