CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Article No. NA6050411, Valiant PhD No. 1 Econo recalled
Ivoclar Vivadent is recalling Article No. NA6050411, Valiant PhD No. 1 Econo, distributed nationwide in the US. The recall was initiated on 21 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1006-2024
- FDA event ID
- 93796
- Recalling firm
- Ivoclar Vivadent, Amherst, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Dec 2023
- FDA classified
- 7 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 21 Dec 2023 | Recall initiated by company | |
| 7 Feb 2024 | Classified by FDA | +48 days |
| 14 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Article No. NA6050411, Valiant PhD No. 1 Econo
Where it was distributed
US Nationwide distribution in the states IN and TN.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI D707NA60504110, Lot Z066SD
Where was it sold?
US Nationwide distribution in the states IN and TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ivoclar Vivadent
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|---|---|---|---|---|---|
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
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