Z-1705-2024 Class II Ongoing
FDA device recall Z-1705-2024 was initiated by IVOCLAR VIVADENT AG on April 5, 2024 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 11330 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- April 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11330 units
Product 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 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 Pattern
US Nationwide distribution.
Code Information
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