Medical Device Recall: Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A P
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: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
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-2883-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.