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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 Softw

Medical DevicesSource: FDA (device) · Date: 2026-08-12

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of Texas and Michigan.
Recall initiated
2026-05-20
Code info
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
Product quantity
2
Voluntary mandated
Voluntary: Firm initiated
City
Kaohsiung
Country
Taiwan
Event id
99026
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