Biomet recalls a specific proximal humerus plate model due to incomplete design history files before distribution. This may pose risks during surgical procedures. Affected patients should contact Biomet for guidance.
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 surgery.
The product was distributed without completing necessary design history files. This means the device might not meet safety standards for surgical use, potentially causing complications during bone fracture repair.
Patients who received this specific plate model for bone surgery are affected. Surgeons using this model during procedures are at risk if the design history files were incomplete.
Check for the product name 'A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM' with item number 110030208. The lot number 356270 is also associated with this model.
Reach out to Biomet directly to confirm if you have the recalled plate model and get instructions for next steps.
The product was distributed without completing required design history files, which could affect surgical safety.
The recall indicates potential safety risks due to incomplete design history files, but the exact risk level is not specified in the notice.
Check for the product name 'A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM' with item number 110030208 and lot number 356270.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2317-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2317-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
