A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - 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 issued a recall for the A.L.P.S. Proximal Humerus Plating System High Plate Right 7 Hole 140MM (Item Number 110030407), a device intended for temporary internal fixation and stabilization of bone fractures and surgical cuts. The product was distributed to the field without completion of design history files or design transfer activities. The affected lot is Lot Number 408910 with specific product code identifiers, and the device was distributed worldwide including to the United States (specifically NY, GA, FL, and MO) and internationally to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
The recall record does not specify a remedy or action that affected consumers should take.
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: 408910 (01)00887868134876(17)270519(10)408910
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.