FDA Enforcement
Class II
Ongoing
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
Recall: Z-1707-2024
·
Reported May 8, 2024
Enforcement
- Recall Number
- Z-1707-2024
- Event ID
- 94401
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- IVOCLAR VIVADENT AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 8, 2024
- Initiation Date
- April 5, 2024
- Classification Date
- April 30, 2024
- Address
- BEDERSRASSE, LIECHTSTEIN, N/A, Germany
Description
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
Reason
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Code Info
UDI-DI: (01)07615208438635 (11)231130 (10)Z065M0 (241)758441; (01)07615208438635 (11)240112 (10)Z06CBH (241)758441 Batch No. Z065M0, Z06CBH
Distribution
US Nationwide distribution.
Quantity
4080 units