FDA Enforcement
Class II
Ongoing
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
Recall: Z-1705-2024
·
Reported May 8, 2024
Enforcement
- Recall Number
- Z-1705-2024
- 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 A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
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)07615208438666 (11)231117 (10)Z063MX (241)758438; (01)07615208438666 (11)231214 (10)Z067JH (241)758438; (01)07615208438666 (11)240105 (10)Z06B6Y (241)758438; (01)07615208438666 (11)240118 (10)Z06D4N (241)758438 Batch No. Z063MX, Z067JH, Z067J9, Z06B6Y, Z06D4N
Distribution
US Nationwide distribution.
Quantity
11330 units