Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Check against the official notice below — it lists the full affected range.
Biomet recalled the 6.5 Cannulated Screw Tap, a bone fixation screw intended for temporary internal fixation and stabilization of osteotomies and fractures. The product was distributed to the field without completed design history files or design transfer activities. Six units were distributed worldwide, including to the United States (in New York, Georgia, Florida, and Missouri) and internationally to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. The recalled product includes Lot Numbers 624820 and 867200.
The recall source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Distributed to the field without having completed design history files or design transfer activities
Reason for recall: Distributed to the field without having completed design history files or design transfer activities Distribution: Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS. Quantity: 6 OUS Lot/code info: Lot Number: 624820 (01)00887868133732(17)260415(10)624820 867200 (01)00887868133732(17)260731(10)867200
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.