Class II

Medical Device Recall: 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

IVOCLAR VIVADENT AG · April 5, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

11330 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1705-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

IVOCLAR VIVADENT AG Medical Device Recall: 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 | SafeCheck