United Orthopedic Corp.: Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 So

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 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34

UPC codes

04719886906929, 04719886906936, 04719886906943, 04719886906950, 04719886906967, 04719886906424, 04719886906974, 04719886906981, 04719886906998, 04719886907001, 04719886907018, 04719886907025

Source

Official record: FDA (Device enforcement) ↗

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