Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A
Zimmer, Inc.
The hazard
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: 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 Lot Code: Model No. 42-5572-066-10Model UDI-DI (01)00889024561014(17)331103(10)66232947Model Lot number 66232947UPC 00889024561014Would you have heard about this one?
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