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.
Recall
- Recall Number
- Z-0955-2017
- Event Number
- 75782
- Firm
- Voco GmbH Anton-Flettner-Strasse 1-3 Cuxhaven Germany
- FEI Number
- 3002718942
- Product Code
- KLE
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- November 3, 2016
- Posted
- January 6, 2017
- Terminated
- August 23, 2017
Description
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.
Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.
Voco Gmbh notified consignees via email on/about November 3, 2016. The consignees were informed about the incorrect labeling and requested not to use this affected lot as well as to return it. They were also requested to pass this information to their customers
Nationwide Distribution to FL, IA, NH, PA, SC and TX
50 units