Medical device recalls Moderate risk

Ivoclar Vivadent, Inc. recalls Article No. NA6050411, Valiant PhD No. 1 Econo

Recall date
December 21, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1006-2024
FDA classification
Class II
Brand / firm
Ivoclar Vivadent, Inc.
Sold / distributed
US Nationwide distribution in the states IN and TN.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Article No. NA6050411, Valiant PhD No. 1 Econo

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