FDA recall Z-1708-2024

Product

IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443

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.

Key facts

Status

Ongoing

Initiation date

2024-04-05

Report date

2024-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

LIECHTSTEIN, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1708-2024