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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

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 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51
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-2885-2026
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
View on openFDA