Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
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 adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 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 9323-5333Model UDI-DI 04719886908084Model Lot number 25FB50 Product number 9323-5334Model UDI-DI 04719886908091Model Lot number 25FB51UPC 04719886908084UPC 04719886908091Would you have heard about this one?
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