A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - 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 Proximal Humerus Plate Template 140MM (Item Number 110025472), intended for temporary internal fixation and stabilization of osteotomies, without completing required design history files or design transfer activities. A total of 78 units were distributed worldwide to the United States, Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands across three specific lot numbers (429698, 451853, and 462794).
The recall record 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: 78 OUS Lot/code info: Lot Number: 429698 (01)00887868151347(10)429698 451853 (01)00887868151347(10)451853 462794 (01)00887868151347(10)462794
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.