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United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number:

Recalled August 12, 2026 · FDA recall Z-2883-2026 · United Orthopedic

Hazard
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. · FDA Class II
Units
2
Sold at
US Nationwide distribution in the states of Texas and Michigan.

Description

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Product
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
Manufacturer(s)
United Orthopedic Corp.
Made in
Taiwan

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov