PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 8, 2024 Initiated: April 5, 2024 #Z-1708-2024

Product Description

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

Details

Recalling Firm
IVOCLAR VIVADENT AG
Units Affected
2472 units
Distribution
US Nationwide distribution.
Location
LIECHTSTEIN

Frequently Asked Questions

What product was recalled?
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. Recalled by IVOCLAR VIVADENT AG. Units affected: 2472 units.
Why was this product recalled?
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Which agency issued this recall?
This recall was issued by the FDA Devices on May 8, 2024. Severity: Moderate. Recall number: Z-1708-2024.