Z-0028-2020 Class II Terminated
FDA device recall Z-0028-2020 was initiated by Voco GmbH on July 9, 2019 and is designated Class II. Reason for recall: The metal cannula are potentially too loose and may become loose when applying the filing material. The recall status is terminated (terminated April 20, 2023). Affected quantity: 5 units.
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