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Recall Observatory FDA recall evidence

Device product

Article No. NA6050411, Valiant PhD No. 1 Econo

Z-1006-2024

December 21, 2023

Class II

Product summary

Firm
Ivoclar Vivadent, Inc.
Event
Event 93796
Status
Ongoing
Classification
Class II
Quantity
2 boxes (500 per box)
Official record key
device-enforcement:Z-1006-2024

Official wording

Reason: 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.

Code information: UDI-DI D707NA60504110, Lot Z066SD

Distribution pattern: US Nationwide distribution in the states IN and TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.