Medical device manufacturer, Sybron Dental Specialties, Inc., has issued a Field Safety Notice concerning the recall of one lot of K3 Gutta Percha.
The manufacturer found that one lot of K3 Gutta Percha box labeled as part number 825-0625, which is the red-band #25 tip Gutta Percha, actually contain blue-band #30 tip Gutta Percha (part number 825-0630). According to the manufacturer, the product will function as expected and there are no safety or efficacy issues.
According to the local supplier, the affected products were not distributed in Hong Kong. If you are in possession of the affected product, please contact your supplier for necessary actions.