Recall Z-0668-2018 ยท EBF Material, Tooth Shade, Resin
Ivoclar Vivadent, Inc.
Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
| Date | Aug 3, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent letters to consignees on August 3, 2017 instructing them to segregate the recalled product and arrange for a replacement of stock. |
| Quantity | 2 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884588 | HELIOMOLAR(R) DENTAL RESTORATIVE Williams Dental Co., Inc., Jan 27, 1989 |