FDAHealthMay 20, 2026
United Orthopedic Corp. — 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 Descript
⚠️ Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 20, 2026
US Nationwide distribution in the states of Texas and Michigan.
What's affected?
- 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
- Lot code
- Product
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2.
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