TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
- Why
- Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
- Distributed
- US Nationwide distribution in the states of Texas and Michigan.
- Company
- United Orthopedic Corp.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2897-2026 · retrieved 6 August 2026
Read the official notice