CLASS III Device recall · Reported 28 Feb 2018 · FDA Enforcement Report
Heliomolar Refill . 210/A3, Product recalled by Ivoclar Vivadent
Ivoclar Vivadent is recalling Heliomolar Refill . 210/A3. The recall was initiated on 3 Aug 2017 and the FDA has classified it as Class III.
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-0667-2018
- FDA event ID
- 79064
- Recalling firm
- Ivoclar Vivadent, Amherst, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Aug 2017
- FDA classified
- 21 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Aug 2017 | Recall initiated by company | |
| 21 Feb 2018 | Classified by FDA | +202 days |
| 28 Feb 2018 | 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
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Product as listed by the FDA
Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
Where it was distributed
US and Canada
Questions about this recall
Why was it recalled?
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Which lots are affected?
Batch: V37905, Exp. date: 21.10.2020; Batch: V45006, Exp. date: 04.12.2020; Batch: V49583, Exp. date: 12.01.2021; Batch: W04412, Exp. date: 20.02.2021; Batch: W13322, Exp. date: 07.04.2021
Where was it sold?
US and Canada
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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
3 other products · FDA event 79064This product is part of a recall event; the main page for the event is Heliomolar Refill . 110/A1, Product recalled by Ivoclar Vivadent.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Heliomolar Refill . 110/A1, Product recalled by Ivoclar Vivadent | Ivoclar Vivadent | Other | NY | |
| CLASS III | Heliomolar Refill . 140/A2, Product recalled by Ivoclar Vivadent | Ivoclar Vivadent | Other | NY | |
| CLASS III | Heliomolar Refill . 110T, Product recalled by Ivoclar Vivadent | Ivoclar Vivadent | Other | NY |
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 |
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