Article No. NA6050411, Valiant PhD No. 1 Econo
FDA Recall #Z-1006-2024 — Class II — December 21, 2023
Product Description
Article No. NA6050411, Valiant PhD No. 1 Econo
Reason for Recall
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.
Recalling Firm
Ivoclar Vivadent, Inc. — Amherst, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 boxes (500 per box)
Distribution
US Nationwide distribution in the states IN and TN.
Code Information
UDI-DI D707NA60504110, Lot Z066SD
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated