medical MODERATE Updated 2026-08-12

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

See all recalls from United Orthopedic Corp. →

Recalled 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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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Search Amazon for Brand Name: USTAR II →

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View official government recall

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