IVOCLAR VIVADENT AG recalls IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration

Recalled May 8, 2024 · FDA recall Z-1706-2024 · IVOCLAR VIVADENT AG

Hazard

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

Units

12525 units

Sold at

US Nationwide distribution.

Description

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

Product

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

Manufacturer(s)

IVOCLAR VIVADENT AG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →