FDAFDA · Food and drugs·Recall number Z-2886-2026
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Published August 12, 2026 · Recall initiated: May 20, 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 an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
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
- Product Number; UDI-DI Code; Lot Code: Product number 9323-5335; UDI-DI 04719886906554; Lot number 25FB64 Product number 9323-5337; UDI-DI 04719886906578; Lot number 25FB48 Product number 9323-5339; UDI-DI 04719886906592; Lot number 25FB52 Product number 9323-5336; UDI-DI 04719886906561; Lot number 25FB65 Product number 9323-5338; UDI-DI 04719886906585; Lot number 25FB49 Product number 9323-5340; UDI-DI 04719886906608; Lot number 25FB53
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Taiwan
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