FDAFDA · Food and drugs·Recall number Z-2884-2026
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
Published August 12, 2026 · Recall initiated: May 20, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- United Orthopedic Corp.
- Distributor
- US Nationwide distribution in the states of Texas and Michigan.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Taiwan
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