Medical Device Recall: 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,
United Orthopedic Corp. · May 20, 2026
Reason for Recall
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Product Description
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
Distribution
US Nationwide distribution in the states of Texas and Michigan.
States Affected
NATIONWIDE
Quantity Affected
2
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2886-2026
Status: ongoing
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