Recall Z-2883-2026— United Orthopedic Corp.
Class II · Ongoing
Class II FDA medical device recall by United Orthopedic Corp., initiated 2026-05-20. It names one FDA 510(k) clearance: K082424. 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. Reason: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail..
- Recalling firm
- United Orthopedic Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-20
- Firm location
- Kaohsiung, Taiwan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Data sourced from openFDA. This site is unofficial and independent of the FDA.