Biomet recalls 8.0 Cannulated Screw Tap-Bone fixation screws (item 110008467) due to incomplete design history files. These screws are intended for temporary fracture stabilization during healing.
Distributed to the field without having completed design history files or design transfer activities
Biomet is recalling 8.0 Cannulated Screw Tap-Bone fixation screws (item 110008467) because they were distributed without completing required design history files. This could affect surgical safety during temporary fracture stabilization.
The screws were distributed without completing necessary design history files, which is a regulatory requirement for medical devices. This could lead to safety issues if the device does not meet intended use standards during surgery.
Surgical patients who received this specific screw model for temporary fracture fixation. Surgeons and medical facilities using the product are most at risk.
Check for the product name '8.0 Cannulated Screw Tap-Bone fixation screw' with item number 110008467. The lot numbers listed in the recall include specific sequences like 624830 and 867210.
Identify the item number 110008467 and lot numbers starting with 624830 or 867210 to confirm if your product is affected.
The product was distributed without completing required design history files, which is a regulatory requirement for medical devices.
Check the item number and lot numbers to see if your product is affected; the recall does not specify a remedy.
The recall states the product was distributed without completing design history files, but does not describe specific injury risks.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2304-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2304-2020 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.
