A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - 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 recalled A.L.P.S. T15 Low Profile Cortical Screws (3.5mm x 28mm, Item Number 110017628) used for temporary internal fixation and stabilization of bone fractures and osteotomies. The screws were distributed to the field before the company completed required design history files and design transfer activities. The affected lot number is J3835075, and the recall involved 15 units distributed worldwide to locations including the United States (specifically New York, Georgia, Florida, and Missouri) and internationally to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
The recall record does not specify a remedy or instructions 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: 15 OUS Lot/code info: Lot Number: J3835075 (01)00887868131769(17)260722(10)J3835075
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.