Official recall notice

FDA DeviceClass IINotable

FDA Recall: Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog N

Recall date
2026-08-12
FDA class
Class II

Why it was recalled

Hazard

Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

Product description

Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

Affected products

Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58

Verify with the official notice →
Share:

Related Recalls

2026-08-12 · FDA_DEVICE
FDA Recall: Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left a
United Orthopedic Corp.
2026-08-12 · FDA_DEVICE
FDA Recall: Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-
United Orthopedic Corp.
2026-08-12 · FDA_DEVICE
FDA Recall: Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog N
United Orthopedic Corp.
2026-08-12 · FDA_DEVICE
FDA Recall: Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalo
United Orthopedic Corp.