# FDA recall Z-0028-2020

> **Voco GmbH** · Class II · device recall initiated 2019-07-09.

## 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.).

## Reason for recall

The metal cannula are potentially too loose and may become loose when applying the filing material.

## Distribution

Distributed in the US to Iowa and New York

## Key facts

- **Recall number:** Z-0028-2020
- **Recalling firm:** Voco GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-09
- **Report date:** 2019-10-09
- **Termination date:** 2023-04-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cuxhaven, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0028-2020

## Citation

> AI Analytics. FDA recall Z-0028-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0028-2020. Source: US FDA. Licensed CC0.

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