FDAHealthMarch 19, 2026
United Orthopedic Corp. — 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 Ortho
⚠️ Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 19, 2026
US Nationwide distribution in the states of Texas and Michigan.
What's affected?
- 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
- Lot code
- Product
Additional details
Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3.
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