Device recall
Z-0668-2018: Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
FDA device recall · Class III · Ivoclar Vivadent, Inc.
Key facts
| Recall number (Z-number) | Z-0668-2018 |
|---|---|
| Recall event | 79064 |
| Product | Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 |
| Product code | EBF |
| Recalling firm | Ivoclar Vivadent, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 28, 2018 |
| 510(k) numbers | K884588 |
| FEI number | 1316092 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database