A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - 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 has recalled the A.L.P.S. Proximal Humerus Plating System Proximal Humerus Plate Template 90MM (Item Number: 110025471) used for temporary internal fixation and stabilization of bone cuts. The product was distributed worldwide, including throughout the United States and to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. A total of 78 units were affected across Lot Numbers 429698 and 452448.
The recall was issued because the product was distributed to the field without completed design history files or design transfer activities. The source document does not specify a remedy or recommended action for consumers or healthcare providers who may have received 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: 78 OUS Lot/code info: Lot Number: 429698 (01)00887868151330(10)429698 452448 (01)00887868151330(10)452448
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.