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
Class II
- Recalling firm
- United Orthopedic Corp.
- Reason for recall
- Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Affected products (lot / model / serial)
- 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
- Units affected
- 2
- Distribution pattern
- US Nationwide distribution in the states of Texas and Michigan.
- Firm location
- Kaohsiung, Taiwan
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2886-2026
- Recall initiated
- May 20, 2026
- FDA classification date
- August 5, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99026
- Last updated on HTM Vibe
- August 18, 2026
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