Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - 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 8.0 Cannulated Screw Tap-Bone fixation screw (Item Number 110008467), a device intended for temporary internal fixation and stabilization of fractures and osteotomies. The product was distributed worldwide, including throughout the United States and to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. The recall involved approximately 10 units from multiple lots distributed to the field.
The reason for the recall was that the product was distributed without having completed design history files or design transfer activities. The source record 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: 10 OUS Lot/code info: Lot Number: 624830 (01)00887868133749(17)260414(10)624830 867210 (01)00887868133749(17)260730(10)867210
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.