Device product
Article No. NA6050411, Valiant PhD No. 1 Econo
Z-1006-2024
Product summary
- 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
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.