A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - 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 the A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM (Item Number: 110030209), a device intended for temporary internal fixation and stabilization of bone fractures and surgical cuts. The product was distributed to the field without completed design history files or design transfer activities. Two units were affected—one distributed in the United States and one internationally—with worldwide distribution documented in the US, Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. The affected lots are identified as Lot Number 356280 and RM256H.
The source document does not specify a remedy or corrective action that consumers should take.
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 US and 1 OUS Lot/code info: Lot Number: 356280 (01)00887868134838(17)270716(10)356280; RM256H (01)00887868134838(17)260304(10)RM256H
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.