A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - 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 A.L.P.S. Proximal Humerus Plating System 3.2MM Calibrated Drill Bit (Item Number: 110017737) because it was distributed without completion of design history files or design transfer activities. The drill bit is intended for temporary internal fixation and stabilization of osteotomies and fractures. Approximately 15 units were distributed worldwide, including throughout the United States (specifically in New York, Georgia, Florida, and Missouri) and internationally to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. The affected product carries Lot Number 054380 with expiration date of November 11, 2025.
The recall notice does not specify a remedy or corrective 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: 15 OUS Lot/code info: Lot Number: 054380 (01)00887868134845(17)251111(10)054380
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.