A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - 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 its A.L.P.S. Proximal Humerus Plating System High Plate Right 14 Hole 234MM (Item Number 110030409) to the field without completing required design history files or design transfer activities. This device is intended for temporary internal fixation and stabilization of bone fractures and related procedures. Two units of Lot Number 356320 were distributed worldwide, including to the United States (specifically New York, Georgia, Florida, and Missouri) and internationally to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
The recall record does not specify what actions affected consumers or healthcare facilities should take regarding this product.
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: 2 OUS Lot/code info: Lot Number: 356320 (01)00887868134890(17)270720(10)356320
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.