Events

Safety Alert for Cheek Retractor, f/MatrixMANDIBLE U-shaped, Flexible

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Synthes GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-12-23
  • Event Date Posted
    2014-12-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141223.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: synthes gmbh cheek retractor, f/matrixmandible u-shaped, flexible 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.

Device

Cheek Retractor, f/MatrixMANDIBLE U-shaped, Flexible
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes GmbH Cheek Retractor, f/MatrixMANDIBLE U-shaped, Flexible
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH