Biomet recalls 90mm proximal humerus plate template for missing design history files. This could affect surgical safety during fracture repair. Contact Biomet for details.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific 90mm proximal humerus plate template used in surgery. The recall happens because the product was distributed without completing required design history files, which could impact surgical safety.
The product was distributed without completing design history files or design transfer activities. This means the surgical template might not meet safety standards for fracture repair, potentially causing complications during surgery.
Surgical teams using this specific plate template for fracture repair are affected. Patients undergoing surgery with this template may be at risk if the design files were incomplete.
Check for the item number 110025471 on the plate template. This product was sold with lot numbers starting with 429698 or 452448.
Look for the item number 110025471 and lot numbers starting with 429698 or 452448 on the plate template.
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 potential safety concerns due to incomplete design history files, but the record does not specify if it's safe to use.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2312-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2312-2020 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.
