TemporaryFDAOngoing
Can cause harm that is usually temporary.
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Check the device or its packaging for
Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51
- Why
- Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Distributed
- US Nationwide distribution in the states of Texas and Michigan.
- Company
- United Orthopedic Corp.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2885-2026 · retrieved 5 August 2026
Read the official notice