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 #1515
    • Lot 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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 23, 2017 · Data as of Sep 19, 5:32 PM UTC

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