Reported Oct 9, 2019 · Terminated
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling…
Voco GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Voco GmbH · Anton-Flettner-Str. 1-3 · Cuxhaven, N/A · N/A
Is this the product you have?
- Grandio SO Heavy Flow Caps
- Color A3 - Product UsageFilling 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.)
- Lot codes and dates
Item Number 2706Lot Number 1923282Expiration Date 12/28/2021
- Amount recalled
- 5 units
Where it was sold
Why it was recalled
The metal cannula are potentially too loose and may become loose when applying the filing material.
This product could cause temporary or reversible health problems — stop using it.
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