FDAJuly 9, 2019device
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 caviti...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The metal cannula are potentially too loose and may become loose when applying the filing material.
What to do
FDA enforcement status: Terminated
Brands named
voco
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAIonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement2024-01-25
- FDAIonolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement2024-01-25
- FDAVOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as ...2016-11-03
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