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.).
Reported: October 9, 2019 Initiated: July 9, 2019 #Z-0028-2020
Product Description
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.
Details
- Recalling Firm
- Voco GmbH
- Units Affected
- 5 units
- Distribution
- Distributed in the US to Iowa and New York
- Location
- Cuxhaven, N/A
Frequently Asked Questions
What product was recalled? ▼
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.).. Recalled by Voco GmbH. Units affected: 5 units.
Why was this product recalled? ▼
The metal cannula are potentially too loose and may become loose when applying the filing material.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2019. Severity: Moderate. Recall number: Z-0028-2020.
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