A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - 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 16 units of the A.L.P.S. Proximal Humerus Plating System Low Plate Left 14 Hole 227MM (Item Number 110030109) to the field without completing required design history files or design transfer activities. This device is intended for temporary internal fixation and stabilization of bone fractures and osteotomies. The affected lot number is 356240, and the product was distributed worldwide, including to the United States (New York, Georgia, Florida, and Missouri) and internationally to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
The source document does not specify a remedy or corrective 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: 16 OUS Lot/code info: Lot Number: 356240 (01)00887868134784(17)270717(10)356240
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.