Medical Device Recall: 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
United Orthopedic Corp. · March 19, 2026
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.
Product 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
Distribution
US Nationwide distribution in the states of Texas and Michigan.
States Affected
NATIONWIDE
Quantity Affected
3
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2898-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.