Voco GmbH recalls Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling smal…

Recall date

July 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0028-2020

FDA classification

Class II

Brand / firm

Voco GmbH

Sold / distributed

Distributed in the US to Iowa and New York

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.).