Home / Recalls / Medical Devices
United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 So
Recalled August 12, 2026 · FDA recall Z-2897-2026 · United Orthopedic
Hazard
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. · FDA Class II
Units
3
Sold at
US Nationwide distribution in the states of Texas and Michigan.
Description
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Product
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Manufacturer(s)
United Orthopedic Corp.
Made in
Taiwan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →