Biomet recalls 6.5 Cannulated Screw Taps (Item 110008466) due to incomplete design history files. These bone fixation screws are intended for temporary use during healing. Affected units have specific lot numbers.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling its 6.5 Cannulated Screw Taps (Item 110008466) because they were distributed without completing required design history files. This could affect the safety of the device during temporary bone fixation procedures.
The device was distributed without completing necessary design history files, which may impact its safety and reliability during medical procedures. This could lead to complications if the screw fails to hold properly during the healing process.
Surgical professionals and patients who have received this bone fixation screw for temporary fracture stabilization are likely affected. The risk is highest for those using the product in medical procedures.
Check for the product name 'Biomet 6.5 Cannulated Screw Tap' and item number 110008466. Affected units have specific lot numbers starting with 624820 or 867200.
Identify the item number (110008466) and lot numbers (624820 or 867200) to confirm if your device is affected.
The recall states the device was distributed without completed design history files, but it does not specify if the product is unsafe in normal use.
The recall does not provide a remedy, so there is no action required beyond checking if your device matches the described lot numbers.
Look for the item number 110008466 and lot numbers starting with 624820 or 867200.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2303-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2303-2020 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.
