Biomet recalls a 140mm proximal humerus plate template for incomplete design history files. This device is used for temporary fracture stabilization. Affected units were distributed without proper design documentation.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a 140mm proximal humerus plate template used in fracture treatment. The recall is because the product was distributed without completing required design history files, which could affect safety during medical procedures.
The product was distributed without completing design history files or design transfer activities. This means the device might not meet safety standards for medical use, potentially leading to complications during fracture treatment.
Medical professionals who use this plate template for temporary fracture stabilization are affected. Patients receiving this device during surgery may be at risk if the design files were incomplete.
Check for the item number 110025472 on the plate template. The product was sold for temporary internal fixation of fractures. Lot numbers include 429698, 451853, and 462794.
Reach out to Biomet directly to confirm if your plate template is affected by this recall.
The product was distributed without completing required design history files or design transfer activities.
The recall record does not specify a remedy, so contact Biomet directly for guidance.
The recall indicates the product was distributed without completing design history files, which may affect safety during medical procedures.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2313-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2313-2020 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.
