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.).
This recall has been terminated (originally issued October 1, 2019).
- Recall Initiated
- July 9, 2019
- Posted
- October 1, 2019
- Terminated
- April 20, 2023
- Recall Number
- Z-0028-2020
- Quantity
- 5 units
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021
Root Cause
Process control
Action Taken
VOCO GmbH notified customers on about 07/09/2019 via email. The letter in the email informed customers that the metal cannula are partly too loose and therefore could become loose when applying the material. VOCO GmbH instructed that affected products must be returned immediately and requested that they notify customers if affected product was further distributed.