Biomet recalls drill block set screws for proximal humerus plating systems due to incomplete design history files. Affected items 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 drill block set screw used in proximal humerus plating systems because it was distributed without completing required design history files. This could lead to potential issues during surgical procedures if the product is used without proper documentation.
The product 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.
Surgical teams and medical professionals who use Biomet's proximal humerus plating systems are likely affected. Patients undergoing related surgeries may be at risk if the recalled screws are used.
Check for the item number 110017551 on the drill block set screw. The product was sold with lot number P0217 (01)00887868135026(10)P0217.
Identify the item number 110017551 and lot number P0217 (01)00887868135026(10)P0217 on the drill block set screw.
The product was distributed without completing required design history files or design transfer activities.
The official recall notice does not specify a remedy or action steps for affected products.
The recall indicates potential issues with the product's design documentation, but specific injury 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-2305-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2305-2020 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.
