FDAFDA · Food and drugs·Recall number Z-1006-2024
Article No. NA6050411, Valiant PhD No. 1 Econo
Published February 14, 2024 · Recall initiated: December 21, 2023
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
Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ivoclar Vivadent, Inc.
- Distributor
- US Nationwide distribution in the states IN and TN.
- Lot
- UDI-DI D707NA60504110, Lot Z066SD
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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