CLASS II Device recall · Reported 14 Dec 2016 · FDA Enforcement Report
Virtual XD Refill Light Body Fast Set Wash Material, ml recalled
Ivoclar Vivadent is recalling Virtual XD Refill Light Body Fast Set Wash Material, ml, distributed nationwide in the US. The recall was initiated on 9 Nov 2016 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-0717-2017
- FDA event ID
- 75620
- Recalling firm
- Ivoclar Vivadent, Amherst, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2016
- FDA classified
- 7 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 9 Nov 2016 | Recall initiated by company | |
| 7 Dec 2016 | Classified by FDA | +28 days |
| 14 Dec 2016 | 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
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Product as listed by the FDA
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Questions about this recall
Why was it recalled?
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Which lots are affected?
Lot No./Expiration Date: UL2395/June 28, 2018; UL2293/Dec 31, 2017; UL2222/Aug 28, 2017; UL2220/July 28, 2017; TL4121/ Mar 28, 2017
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of Canada and Australia
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.
Other products in this recall event
2 other products · FDA event 75620This product is part of a recall event; the main page for the event is Virtual XD Test Pack Heavy/Light Fast Set, ml recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Virtual XD Test Pack Heavy/Light Fast Set, ml recalled | Ivoclar Vivadent | Other | Nationwide | |
| CLASS II | Virtual XD Refill Light Body Regular Set Wash Material, ml recalled | Ivoclar Vivadent | Other | Nationwide |
More recalls from Ivoclar Vivadent
All 44| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |