Drug recall
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes…
FDA recall event 83385 · Class II · Voco GmbH
Key facts
| Event ID | 83385 |
|---|---|
| Recall numbers | Z-0028-2020 |
| Recalling firm | Voco GmbH |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The metal cannula are potentially too loose and may become loose when applying the filing material. |
| Initiation date | Jul 9, 2019 |
| Report date | Oct 9, 2019 |
| Termination date | Apr 20, 2023 |
| City | Cuxhaven |
| Country | Germany |
| FEI number | 3002718942 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: