Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
Voco GmbH
4 recalls • • Categories: Other Medical Devices, Implants & Prosthetics, Infusion Pumps
Class I - Dangerous
Class I - Dangerous
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
The metal cannula are potentially too loose and may become loose when applying the filing material.
Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.