Biomet recalls a specific proximal humerus plating system due to design history files not being completed before distribution. This affects certain surgical implants used in fracture repair. Consumers 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 plate used in fracture repairs because it was distributed without completing required design history files. This means the product may not meet safety standards before being used in surgeries.
The product was distributed without completing necessary design history files or design transfer activities. This could mean the implant does not meet safety standards for surgical use, potentially leading to complications during healing.
Surgical patients who received this specific plate during procedures between 2017 and 2023 are likely affected. Surgeons using this model for fracture repairs are at risk if they have not verified the design status.
Check for the product name 'A.L.P.S. Proximal Humerus Plate Low Plate Left 14 Hole 227MM' with item number 110030109. It was sold between 2017 and 2023 for surgical use.
Reach out to Biomet directly for specific details about your product and next steps.
The recall states the product was distributed without completing design history files, so it may not meet safety standards. Biomet must confirm if it's safe for use.
Check for the product name 'A.L.P.S. Proximal Humerus Plate Low Plate Left 14 Hole 227MM' with item number 110030109. It was sold between 2017 and 2023 for surgical use.
Contact Biomet directly for specific details about your product and next steps.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2316-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2316-2020 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.
