United Orthopedic Corp.: Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description:

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 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51

UPC codes

04719886908084, 04719886908091

Source

Official record: FDA (Device enforcement) ↗

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