A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - 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 distributed the A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM (Item Number 110030308) without completing required design history files or design transfer activities. This device is intended for temporary internal fixation and stabilization of osteotomies and fractures. The affected product had Lot Number 408880 and was distributed worldwide, including throughout the United States (in New York, Georgia, Florida, and Missouri) and internationally in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
The recall source 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: 1 OUS Lot/code info: Lot Number: 408880 (01)00887868134937(17)270517(10)408880
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.