United Orthopedic Corp. recalls Brand Name: USTAR II Knee System Product Name: Hinge Box Trial

Recalling company

United Orthopedic Corp.

Product

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

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 20, 2026

Reported

Aug 12, 2026

Distribution

US Nationwide distribution in the states of Texas and Michigan.

Status

Ongoing

Quantity

2

Lot / codes

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

Company location

Kaohsiung

Recall type

Voluntary: Firm initiated

Recall number

Z-2884-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2884-2026 in the FDA Enforcement Report. Also see FDA recall press releases.