United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor
- Recalling company
- United Orthopedic Corp.
- Product
- 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
- Reason
- Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 20, 2026
- Reported
- Aug 12, 2026
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
- Status
- Ongoing
- Quantity
- 2
- Lot / codes
- 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
- Company location
- Kaohsiung
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2886-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2886-2026 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.