Biomet recalls a 2.7mm drill block guide sleeve for proximal humerus plating systems due to incomplete design history files. This device is used in fracture stabilization during healing. Affected units include specific lot numbers.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a 2.7mm drill block guide sleeve for proximal humerus plating systems because it was distributed without completing required design history files. This could affect surgical procedures and patient safety during fracture healing.
The product was distributed without completing design history files or design transfer activities. This means the device may not meet safety standards for surgical use, potentially leading to complications during fracture stabilization procedures.
Surgical patients and medical professionals who have received this specific drill block guide sleeve for proximal humerus plating systems. The risk is highest for those using the product in surgical procedures.
Check for the product name 'A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeve 2.7mm' with item number 110017563. Affected units include lot number 3287A (01)00887868135071(10)3287A.
Identify the product name and item number to confirm if it matches the recalled item.
The product was distributed without completing required design history files or design transfer activities.
The recall record does not specify a remedy, so check with Biomet for further instructions.
The recall indicates incomplete design history files, but the specific injury risk is not described in the record.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2307-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2307-2020 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.
