FDA recall Z-1006-2024

Ivoclar Vivadent, Inc. · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states IN and TN.

Key facts

Status
Ongoing
Initiation date
2023-12-21
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Amherst, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1006-2024