Brand Name: U2 Total Knee System Product Name: Femoral offset bushing recall (United Orthopedic Corp.)
Medical deviceClass IIOngoing
Summary: United Orthopedic Corp. is recalling 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. Reason: Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
What is being recalled
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
Why
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of Texas and Michigan. (states named: Michigan, Texas)
How to tell if yours is affected
Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2897-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 19, 2026 |
| Reported | August 12, 2026 |
| Company | United Orthopedic Corp. |
| Company location | Kaohsiung, Taiwan |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3 |
More recalls from United Orthopedic Corp. · all medical device recalls · recalls from March 2026