Device recall
Z-0028-2020: Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive…
FDA device recall · Class II · Voco GmbH
Key facts
| Recall number (Z-number) | Z-0028-2020 |
|---|---|
| Recall event | 83385 |
| Product | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities… |
| Product code | EBF |
| Recalling firm | Voco GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 20, 2023 |
| 510(k) numbers | K102354 |
| FEI number | 3002718942 |
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