Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left a
- Recall date
- 2026-08-12
- Category
- Medical Device
- 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 9323-5335; 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