A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - 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 is recalling the A.L.P.S. Proximal Humerus Plating System Proximal Humerus Plate Template 234MM (Item Number 110025473), a device intended for temporary internal fixation and stabilization of bone cuts. The device was distributed worldwide, including to the United States and several other countries including Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. A total of 48 units were distributed under lot numbers 452448 and 462794.
The recall was issued because the product was distributed to the field without having completed design history files or design transfer activities. 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: 48 OUS Lot/code info: Lot Number: 452448 (01)00887868151354(10)452448 462794 (01)00887868151354(10)462794
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.