FDAFDA recall Z-2897-2026 · Aug 12, 2026
United Orthopedic Corp.: Brand Name: U2 Total Knee System Product Name: Femoral offset bushing recall
Recall found
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 for recall
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
- Quantity
- 3
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
- Recalling firm
- United Orthopedic Corp., Kaohsiung
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-03-19
Source: openFDA enforcement record Z-2897-2026 · search recall number Z-2897-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.