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Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

Class II
Recalling firm
United Orthopedic Corp.
Reason for recall
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Affected products (lot / model / serial)
Product Number; UDI-DI Code; Lot Code: Product number 9325-5711; UDI-DI 04719886907032; Lot number 25FB41 Product number 9325-5712; UDI-DI 04719886907049; Lot number 25FB42 Product number 9325-5713; UDI-DI 04719886907056; Lot number 25FB43 Product number 9325-5714; UDI-DI 04719886907063; Lot number 25FB44 Product number 9325-5715; UDI-DI 04719886907070; Lot number 25FB45 Product number 9325-5716; UDI-DI 04719886907087; Lot number 25FB46 Product number 9325-5721; UDI-DI 04719886907094; Lot number 25FB35 Product number 9325-5722; UDI-DI 04719886907100; Lot number 25FB36 Product number 9325-5723; UDI-DI 04719886907117; Lot number 25FB37 Product number 9325-5724; UDI-DI 04719886907124; Lot number 25FB38 Product number 9325-5725; UDI-DI 04719886907131; Lot number 25FB39 Product number 9325-5726; UDI-DI 04719886907148; Lot number 25FB40
Units affected
2
Distribution pattern
US Nationwide distribution in the states of Texas and Michigan.
Firm location
Kaohsiung, Taiwan
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2884-2026
Recall initiated
May 20, 2026
FDA classification date
August 5, 2026
FDA report date
August 12, 2026
FDA event ID
99026
Last updated on HTM Vibe
August 18, 2026
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