United Orthopedic Corp.: Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number:

Hazard

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Details from the source

Reason for recall: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. Distribution: US Nationwide distribution in the states of Texas and Michigan. Quantity: 2 Lot/code info: Product Number; UDI-DI Code; Lot Code: Product number 9323-5335; UDI-DI 04719886906554; Lot number 25FB64 Product number 9323-5337; UDI-DI 04719886906578; Lot number 25FB48 Product number 9323-5339; UDI-DI 04719886906592; Lot number 25FB52 Product number 9323-5336; UDI-DI 04719886906561; Lot number 25FB65 Product number 9323-5338; UDI-DI 04719886906585; Lot number 25FB49 Product number 9323-5340; UDI-DI 04719886906608; Lot number 25FB53

UPC codes

04719886906554, 04719886906578, 04719886906592, 04719886906561, 04719886906585, 04719886906608

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.