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
United Orthopedic Corp.
The hazard
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Product NumberModel UDI-DI CodeModel Lot Code: Product number 9325-5711Model UDI-DI 04719886907032Model Lot number 25FB41 Product number 9325-5712Model UDI-DI 04719886907049Model Lot number 25FB42 Product number 9325-5713Model UDI-DI 04719886907056Model Lot number 25FB43 Product number 9325-5714Model UDI-DI 04719886907063Model Lot number 25FB44 Product number 9325-5715Model UDI-DI 04719886907070Model Lot number 25FB45 Product number 9325-5716Model UDI-DI 04719886907087Model Lot number 25FB46 Product number 9325-5721Model UDI-DI 04719886907094Model Lot number 25FB35 Product number 9325-5722Model UDI-DI 04719886907100Model Lot number 25FB36 Product number 9325-5723Model UDI-DI 04719886907117Model Lot number 25FB37 Product number 9325-5724Model UDI-DI 04719886907124Model Lot number 25FB38 Product number 9325-5725Model UDI-DI 04719886907131Model Lot number 25FB39 Product number 9325-5726UPC 04719886907032UPC 04719886907049UPC 04719886907056UPC 04719886907063UPC 04719886907070UPC 04719886907087UPC 04719886907094UPC 04719886907100UPC 04719886907117UPC 04719886907124UPC 04719886907131UPC 04719886907148Would you have heard about this one?
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