Official recall notice

FDA DeviceClass IINotable

FDA Recall: Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm 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 9323-5312; UDI-DI 04719886908077; Lot number 25FC64

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