Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all ...
FDA Device Recall #Z-0028-2020 — Class II — July 9, 2019
Recall Summary
| Recall Number | Z-0028-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 9, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Voco GmbH |
| Location | Cuxhaven, N/A |
| Product Type | Devices |
| Quantity | 5 units |
Product Description
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.).
Reason for Recall
The metal cannula are potentially too loose and may become loose when applying the filing material.
Distribution Pattern
Distributed in the US to Iowa and New York
Lot / Code Information
Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021
Other Recalls from Voco GmbH
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1143-2024 | Class II | Ionolux, Catalog (REF) Numbers: a) 2115, b)211... | Jan 25, 2024 |
| Z-1142-2024 | Class II | IonoStar Plus, Catalog (REF) Numbers: a) 2540,... | Jan 25, 2024 |
| Z-0955-2017 | Class II | VOCO Futurabond M+ adhesive, RF 1515, Manufactu... | Nov 3, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.