United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral offset bushing
- Recalling company
- United Orthopedic Corp.
- 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
- Reason
- Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 19, 2026
- Reported
- Aug 12, 2026
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
- Status
- Ongoing
- Quantity
- 3
- Lot / codes
- Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
- Company location
- Kaohsiung
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2897-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2897-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.