Z-0028-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- July 9, 2019
- Termination Date
- April 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
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 Pattern
Distributed in the US to Iowa and New York
Code Information
Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021