FDAFDA · Food and drugs·Recall number Z-2898-2026
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
Published August 12, 2026 · Recall initiated: March 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- United Orthopedic Corp.
- Distributor
- US Nationwide distribution in the states of Texas and Michigan.
- Lot
- Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Taiwan
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