Biomet recalls a specific proximal humerus plating system due to incomplete design history files before distribution. This may affect surgical implants used in fracture repair. Affected units require verification of lot numbers and item numbers.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific type of proximal humerus plating system used in fracture repair. The recall is because the product was distributed without completing required design history files, which could lead to safety issues during surgical use.
The product was distributed without completing necessary design history files, which are required to ensure the device meets safety standards before being used in surgery. This could mean the device might not function properly or could cause complications during the healing process.
Surgical patients who received this specific plate model (Item Number 110030308) during procedures between 2017 and 2023 are likely affected. Surgeons and medical facilities using this product are at highest risk.
Check for the item number 110030308 on the plate packaging or label. The product was sold between 2017 and 2023 with lot number 408880.
Check the item number on the plate packaging or label to confirm it matches 110030308.
The product was distributed without completing required design history files, which are necessary for ensuring safety standards in surgical implants.
The official recall notice does not specify a remedy or action for affected units. You should verify the item number and contact Biomet directly for further instructions.
The recall indicates the product was distributed without completing design history files, which could pose safety risks. Affected units should not be used until further instructions are received.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2320-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2320-2020 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.
