Device 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.).
Z-0028-2020
Product summary
- Firm
- Voco GmbH
- Event
- Event 83385
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0028-2020
Official wording
Reason: The metal cannula are potentially too loose and may become loose when applying the filing material.
Code information: Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021
Distribution pattern: Distributed in the US to Iowa and New York
Derived failure modes
-
Unknown
The metal cannula are potentially too loose and may become loose when applying the filing material.