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Medical Device

Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A

Recall date: 2026-08-12 · Source: FDA_DEVICE
Product
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Reason for recall
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Units affected
3
Description
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
View official recall notice →