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Home › FDA recalls › Brand Name: U2 Total Knee System Product Name: Femoral valg
CLASS II · ModerateFDA

United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor

📅 May 20, 2026 · 📍 Nationwide
Recalling company
United Orthopedic Corp.
Product
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
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 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51
Company location
Kaohsiung
Recall type
Voluntary: Firm initiated
Recall number
Z-2885-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2885-2026 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.