FDAFDA · Food and drugs·Recall number Z-0028-2020
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.).
Published October 9, 2019 · Recall initiated: July 9, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The metal cannula are potentially too loose and may become loose when applying the filing material.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Voco GmbH
- Distributor
- Distributed in the US to Iowa and New York
- Lot
- Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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