Recall Z-0028-2020 ยท EBF Material, Tooth Shade, Resin
Voco GmbH
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,
| Date | Oct 1, 2019 (initiated Jul 9, 2019) |
| Status | Terminated |
| Reason | The metal cannula are potentially too loose and may become loose when applying the filing material. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 5 units |
| Distribution | Distributed in the US to Iowa and New York |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102354 | GRANDIO SO HEAVY FLOW Voco GmbH, Nov 8, 2010 |