Medical device manufacturer, Synthes GmbH, has issued a medical device safety alert concerning its Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible [Part number: 397.232; Lot number: 6355110].
According to the manufacturer, the Cheek Retractor for MatrixMANDIBLE U-shaped may not function as intended due to the potential for failure and/or corrosion of the internal spring which has been manufactured from an incorrect material.
There is a potential for subcomponent spring breakage originating from the incorrect raw material used in the fabrication of the spring in the Cheek Retractor for MatrixMANDIBLE U-shaped, flexible. There is a potential for harm to patients including surgical delay if the retractor does not work during a procedure and a replacement needs to be found. Adverse tissue reaction and/or infection could occur if the retractor is used and corroded material from the spring falls into the wound and is not removed during irrigation.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 December 2014