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Voco GmbH recalls Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small
Recalled October 9, 2019 · FDA recall Z-0028-2020 · Voco
Hazard
The metal cannula are potentially too loose and may become loose when applying the filing material. · FDA Class II
Units
5 units
Sold at
Distributed in the US to Iowa and New York
Description
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.).
Manufacturer(s)
Voco GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →