Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthop
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: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
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 9323-5335Model UDI-DI 04719886906554Model Lot number 25FB64 Product number 9323-5337Model UDI-DI 04719886906578Model Lot number 25FB48 Product number 9323-5339Model UDI-DI 04719886906592Model Lot number 25FB52 Product number 9323-5336Model UDI-DI 04719886906561Model Lot number 25FB65 Product number 9323-5338Model UDI-DI 04719886906585Model Lot number 25FB49 Product number 9323-5340Model UDI-DI 04719886906608Model Lot number 25FB53UPC 04719886906554UPC 04719886906578UPC 04719886906592UPC 04719886906561UPC 04719886906585UPC 04719886906608Would you have heard about this one?
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