Biomet recalls 3.2mm calibrated drill bit for proximal humerus plating system due to incomplete design history files. Affected units may pose risks during surgical procedures.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling a specific 3.2mm calibrated drill bit used in orthopedic surgery. The recall is because the product was distributed without completing required design history files, which could lead to safety issues during surgical procedures.
The drill bit was distributed without completing necessary design history files or design transfer activities. This means the product might not meet safety standards for surgical use, potentially causing complications during procedures.
Orthopedic surgeons and medical professionals who use this drill bit for bone fixation procedures are likely affected. Patients receiving this surgical implant may be at risk if the drill bit is used without proper documentation.
The product is a 3.2mm calibrated drill bit for proximal humerus plating systems. It was sold with lot number 054380 (01)00887868134845(17)251111(10)054380 for surgical use.
Verify the lot number on your drill bit to confirm if it matches the affected lot number 054380 (01)00887868134845(17)251111(10)054380.
The drill bit was distributed without completing required design history files or design transfer activities, which could affect surgical safety.
Check the lot number on your drill bit. If it matches the affected lot number 054380 (01)00887868134845(17)251111(10)054380, contact Biomet for further instructions.
The recall is due to incomplete design documentation, which could lead to safety issues during surgical procedures, but specific patient risks are not detailed in the notice.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2309-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2309-2020 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.
