A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - 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 HIGH PLATE RIGHT 11 HOLE 197MM (Item Number: 110030408) because it was distributed to the field without completed design history files or design transfer activities. This device is intended for temporary internal fixation and stabilization of osteotomies. One unit from Lot Number 408920 was affected and distributed worldwide, including to the United States (NY, GA, FL, MO) and internationally to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
The source document 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: 1 OUS Lot/code info: Lot Number: 408920 (01)00887868134883(17)270627(10)408920
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.