Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small
FDA device recall Z-0028-2020 · posted 2019-10-01 · Terminated
Recall details
- Recalling firm
- Voco GmbH
- Reason for recall
- The metal cannula are potentially too loose and may become loose when applying the filing material.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- EBF
- Quantity affected
- 5 units
- Distribution
- Distributed in the US to Iowa and New York
- Date initiated
- 2019-07-09
- Date posted
- 2019-10-01
- Date terminated
- 2023-04-20
- Location
- Cuxhaven, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRANDIO SO HEAVY FLOW (K102354) | Voco GmbH | 2010-11-08 |