United Orthopedic Corp.: Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4
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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 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
- 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 9323-5335; 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
- Product quantity
- 2
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Kaohsiung
- Country
- Taiwan
- Event id
- 99026
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