Cuxhaven, N/A, Germany
Voco GmbH recalls
2 recalls recorded since 2018, most recently on 25 January 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 January 2024
- Reason
- Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
- Distribution
- Worldwide distribution: US distribution to states of: IA, NY, PA, WA; and OUS (foreign) to countries of: Belgium, Bulgaria, Denmark, Germany, France, Greece, Great Britain, India, Italy, Canada, Quatar, Lithuania, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Sweden, Switzerlan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1143-2024, Z-1142-2024
- Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
- IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Terminated Class II Medical devices
- Recall started
- 9 July 2019
- Terminated
- 20 April 2023
- Reason
- The metal cannula are potentially too loose and may become loose when applying the filing material.
- Distribution
- Distributed in the US to Iowa and New York
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0028-2020
- 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 de
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.