FDA recall Z-0028-2020

Voco GmbH · Class II · 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.).

Reason for recall

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

Distribution

Distributed in the US to Iowa and New York

Key facts

Status
Terminated
Initiation date
2019-07-09
Report date
2019-10-09
Termination date
2023-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cuxhaven, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0028-2020