Dental amalgam powder may not triturate properly, affecting restoration strength
Ivoclar Vivadent is recalling dental amalgam powder that may not triturate properly, affecting restoration strength and working characteristics. Dentists should stop using the recalled lot and contact the manufacturer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a functional defect that could compromise dental restoration outcomes. While no illnesses have been reported, the risk that inadequate restorations could lead to complications qualifies as a risk-of-harm scenario.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling dental amalgam powder, Article No. NA6050411 (Valiant PhD No. 1 Econo), because the product may not perform as expected. The amalgam powder may not triturate correctly, and the physical properties including strength, compression resistance, and working time will be adversely affected.
The affected product was distributed nationwide in Indiana and Tennessee. The recall involves 2 boxes containing 500 units each (Lot Z066SD, UDI-DI D707NA60504110).
Dental amalgam powder that does not triturate properly may result in dental restorations that are weaker, less durable, or fail to function as intended. This could necessitate additional dental treatment.
Dentists and dental practices that have received this product should stop using it immediately. Patients who received treatment with this material should consult their dentist to determine whether their restorations are affected. Contact Ivoclar Vivadent for instructions on returning the product and obtaining replacement stock.
The recalled product
- Product
- Article No. NA6050411, Valiant PhD No. 1 Econo
- Manufacturer
- Ivoclar Vivadent, Inc.
- Hazard
- improper-trituration
- material-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI D707NA60504110
- Lot Z066SD
Distribution
Distributed nationwide across the United States.
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