Recall Z-0955-2017 ยท KLE Agent, Tooth Bonding, Resin
Voco GmbH
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 ligh
| Date | Jan 6, 2017 (initiated Nov 3, 2016) |
| Status | Terminated |
| Reason | Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive. |
| Root cause | Labeling mix-ups |
| Action | 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 |
| Quantity | 50 units |
| Distribution | Nationwide Distribution to FL, IA, NH, PA, SC and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141610 | FUTURABOND M+ Voco GmbH, Aug 1, 2014 |