Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 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: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 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 9323-5511Model UDI-DI 04719886906929Model Lot number 25FB54 Product Number 9323-5512Model UDI-DI 04719886906936Model Lot number 25FB55 Product Number 9323-5513Model UDI-DI 04719886906943Model Lot number 25FB56 Product Number 9323-5514Model UDI-DI 04719886906950Model Lot number 25FB57 Product Number 9323-5515Model UDI-DI 04719886906967Model Lot number 25FB58 Product Number 9323-5516Model UDI-DI 04719886906424Model Lot number 25FB59 Product Number 9323-5521Model UDI-DI 04719886906974Model Lot number 25FB29 Product Number 9323-5522Model UDI-DI 04719886906981Model Lot number 25FB30 Product Number 9323-5523Model UDI-DI 04719886906998Model Lot number 25FB31 Product Number 9323-5524Model UDI-DI 04719886907001Model Lot number 25FB32 Product Number 9323-5525Model UDI-DI 04719886907018Model Lot number 25FB33 Product Number 9323-5526UPC 04719886906929UPC 04719886906936UPC 04719886906943UPC 04719886906950UPC 04719886906967UPC 04719886906424UPC 04719886906974UPC 04719886906981UPC 04719886906998UPC 04719886907001UPC 04719886907018UPC 04719886907025Would you have heard about this one?
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