Reported Jan 18, 2017 · Terminated
VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with…
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-Strasse 1-3 · Cuxhaven · N/A
Is this the product you have?
- VOCO 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 well as without (self-etch). A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / Ormocer materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light-curing luting composites. [B] Intraoral repair of composite, compomer or Ormocer restorations, ceramic veneers and allceramic restorations without an additional primer. [C] Treatment of hypersensitive tooth necks. [D] Protective varnish for glass ionomer cement restorations. [E1] Sealing of cavities prior to amalgam restorations. [E2] Sealing of cavities and core preparations prior to the temporary luting of indirect restorations. In combination with Futurabond M+
- DCA (Dual Cure Activator)[F1] Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups
- Lot codes and dates
REF #1515Lot no. 1636479
- Amount recalled
- 50 units
Where it was sold
Why it was recalled
Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
This product could cause temporary or reversible health problems — stop using it.
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