IVOCLAR VIVADENT AG: IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438

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: 11330 units Lot/code info: UDI-DI: (01)07615208438666 (11)231117 (10)Z063MX (241)758438; (01)07615208438666 (11)231214 (10)Z067JH (241)758438; (01)07615208438666 (11)240105 (10)Z06B6Y (241)758438; (01)07615208438666 (11)240118 (10)Z06D4N (241)758438 Batch No. Z063MX, Z067JH, Z067J9, Z06B6Y, Z06D4N

UPC codes

07615208438666

Source

Official record: FDA (Device enforcement) ↗

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