A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - 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 a Low Plate Right 11 Hole 190mm component (Item Number: 110030208) of the A.L.P.S. Proximal Humerus Plating System without completing required design history files and design transfer activities. This product is intended for temporary internal fixation and stabilization of bone breaks and surgical cuts. One unit with Lot Number 356270 was distributed worldwide, including to the United States (specifically NY, GA, FL, and MO) and to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
The source document does not specify what affected consumers should do regarding this recall.
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: 356270 (01)00887868134821(17)270718(10)356270
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.