Class II — Voco GmbH
| Recalling firm | VOCO GMBH |
|---|---|
| Registered facility | VOCO GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The metal cannula are potentially too loose and may become loose when applying the filing material. |
| 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 - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.). |
| Quantity | 5 units |
| Distribution | Distributed in the US to Iowa and New York |
| Initiated | 2019-07-09 |
| Classified | 2019-10-01 |
| Terminated | 2023-04-20 |
| Recall number | Z-0028-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Voco GmbH (Z-0028-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83385/
Alerts for VOCO GMBH
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.