Recall Z-0667-2018
Ivoclar Vivadent, Inc. · initiated August 3, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
Codes / lots: 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
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
The firm sent letters to consignees on August 3, 2017 instructing them to segregate the recalled product and arrange for a replacement of stock.
Details
- Recall number
- Z-0667-2018
- Initiated
- August 3, 2017
- Terminated
- August 28, 2018
- Product code
- EBF – Material, Tooth Shade, Resin
- Quantity
- 1,244 units
- Distribution
- US and Canada
- Recalling firm
- Ivoclar Vivadent, Inc., Amherst, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0665-2018 Class III | Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its… | 08/03/2017Terminated |
| Z-0666-2018 Class III | Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its… | 08/03/2017Terminated |
| Z-0668-2018 Class III | Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its… | 08/03/2017Terminated |