A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - 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 the A.L.P.S. T15 Multi-Directional Locking Screw (3.5mm x 60mm, Item Number 110017960) to the field without completing required design history files or design transfer activities. This medical device is intended for temporary internal fixation and stabilization of osteotomies and fractures. The affected product was distributed worldwide, including throughout the United States in New York, Georgia, Florida, and Missouri, as well as in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. A total of 15 units outside the United States were involved, identified by Lot Number RM540H with expiration date 06/23/2026.
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: 15 OUS Lot/code info: Lot Number: RM540H (01)00887868132490(17)260623(10)RM540H
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.