Medical device manufacturer, Kerr Corporation, has issued a medical device safety alert concerning its PREMISA Unidose Refills - A3.5 (Part number: 32814; Lot number: 5641195; Shipped between November 2015 to December 2015)
It has recently come to the manufacturer's attention that an issue with the production process used to package the affected lots of Premisa may lead to the presence of plastic particulates in the dental composite material. The particulate is visible to Doctors and should be easy to remove prior to or even after curing. Furthermore, the particulate is unlikely to cause any adverse health consequences. There is no need to replace any restorations placed with this material.
Product recall and replacement is on-going.
According to the manufacturer, the affected products are distributed in Hong Kong. If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 2 February 2017