A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - 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. Proximal Humerus Plating System 3.2MM Locking Pegs (60MM, Item Number 110025460) used for temporary internal fixation and stabilization of bone fractures and osteotomies. The recall was issued because these devices were distributed to the field before design history files and design transfer activities were completed. Approximately 15 units were distributed worldwide, including across the United States (NY, GA, FL, MO) and internationally to Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. The affected lot number is J3853404.
The source document does not specify a remedy or instructions for 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: 15 OUS Lot/code info: Lot Number: J3853404 (01)00887868134500(17)260813(10)J3853404
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.