IVOCLAR VIVADENT AG recalls IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration…

Recall date

April 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1707-2024

FDA classification

Class II

Brand / firm

IVOCLAR VIVADENT AG

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441