FDAFDA · Food and drugs·Recall number Z-1703-2024
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
Published May 8, 2024 · Recall initiated: April 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- IVOCLAR VIVADENT AG
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: (01)07615208438703 (11)231117 (10)Z063MW (241)758434 (01)07615208438703 (11)231214 (10)Z067JD(241)758434 Lot Numbers: Z063MW, Z067JD
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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