Z-1704-2024 Class II Ongoing
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
- 7445 units
Product Description
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
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)07615208438673 (11)231214 (10)Z067J5 (241)758437; (01)07615208438673 (11)231214 (10)Z067J6 (241)758437; (01)07615208438673 (11)240112 (10)Z06CBD (241)758437; (01)07615208438673 (11)240112 (10)Z06CBF (241)758437 Batch No. Z067J5, Z067J6, Z06CBD, Z06CBF