IVOCLAR VIVADENT AG: IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439

Hazard

Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration

Details from the source

Reason for recall: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration Distribution: US Nationwide distribution. Quantity: 12525 units Lot/code info: UDI-DI: (01)07615208438659 (11)231117 (10)Z063MT (241)758439; (01)07615208438659 (11)231214 (10)Z067JF (241)758439; (01)07615208438659 (11)231214 (10)Z067JC (241)758439; (01)07615208438659 (11)231214 (10)Z067JG (241)758439; (01)07615208438659 (11)231214 (10)Z067JB (241)758439; (01)07615208438659 (11)240105 (10)Z06B6Z (241)758439; (01)07615208438659 (11)240112 (10)Z06CBG (241)758439 Batch No. Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, Z06CBG

UPC codes

07615208438659

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.