Official recall notice

FDA DeviceClass IINotable

FDA Recall: Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalo

Recall date
2026-08-12
FDA class
Class II

Why it was recalled

Hazard

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

Product description

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

Affected products

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

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