Recall Z-0028-2020
Voco GmbH · initiated July 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.).
Codes / lots: Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021
Reason for recall
The metal cannula are potentially too loose and may become loose when applying the filing material.
FDA-determined 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.
Details
- Recall number
- Z-0028-2020
- Initiated
- July 9, 2019
- Posted by FDA
- October 1, 2019
- Terminated
- April 20, 2023
- Product code
- EBF – Material, Tooth Shade, Resin
- Quantity
- 5 units
- Distribution
- Distributed in the US to Iowa and New York
- Recalling firm
- Voco GmbH, Cuxhaven