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 2706
    • Lot Number 1923282
    • Expiration 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 20, 2023 · Data as of Sep 19, 4:52 PM UTC

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