A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - 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 LEFT 7 HOLE 140MM (Item Number: 110030307), a device intended for temporary internal fixation and stabilization of bone fractures and cuts. The device was distributed to the field without completed design history files or design transfer activities. The affected product was distributed worldwide, including in the United States (specifically in New York, Georgia, Florida, and Missouri) and internationally in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
The recall involves one unit with Lot Number 408870 and barcode 01)00887868134920(17)270519(10)408870. 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: 408870 (01)00887868134920(17)270519(10)408870
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.