Class II

Medical Device Recall: Article No. NA6050411, Valiant PhD No. 1 Econo

Ivoclar Vivadent, Inc. · December 21, 2023

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.

Distribution

US Nationwide distribution in the states IN and TN.

States Affected

NATIONWIDE

Quantity Affected

2 boxes (500 per box)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1006-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.