FDA Medical Device Recalls (openFDA)
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, etc.).
- Recall number
- Z-0028-2020
- Recalling firm
- Voco GmbH
- 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.).
- Status
- Terminated
- Initiated
- 2019-07-09
- Posted
- 2019-10-01
- Terminated
- 2023-04-20
- 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
- Lot, serial or model codes
- Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021
- 510(k) numbers
- ["K102354"]
- PMA numbers
- not on file
- Product code
- EBF
- Firm FEI
- 3002718942
- Firm city
- Cuxhaven
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28