Events

Safety Alert for Mandible Distractor, Monoaxial and Proximal Foot Plate

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

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
    2016-06-15
  • Event Date Posted
    2016-06-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160615.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: mandible distractor, monoaxial and proximal foot plate medical device manufacturer, synthes, has issued a medical device safety alert concerning its mandible distractor, monoaxial and proximal foot plate. according to the manufacturer, the fastener on the mandible distractor may become prematurely separated from the proximal foot plate. in the event that the mandible distractor becomes disengaged from the proximal foot plate during device implantation, surgical delay may occur if another device is not available in the surgical suite. if the mandible distractor becomes disengaged from the proximal foot plate after device implantation, repeat surgery may be required to replace the mandible distractor/foot plates. there may be a risk of local infection as a result of repeat surgery caused by the disengagement since the product is in the oral cavity. there is no replacement device available from the manufacturer. the manufacturer offers several alternative devices which are also intended for distraction of the mandible, including the stainless steel mandible distractor system, the titanium multi-vector distractor module system, and the curvilinear distraction system. according to the local supplier, the following affected products are distributed in hong kong:-. a) mandible distractor, monoaxial, left, distraction length 30mm [part number: 487.965, lot number: 6538904] b) proximal foot plate, left, f/mandib. distractor, monoaxial [part number: 487.975, lot number: 7865426] if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 june 2016.

Device

Mandible Distractor, Monoaxial and Proximal Foot Plate
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Mandible Distractor, Monoaxial and Proximal Foot Plate
  • Manufacturer
    Synthes

Manufacturer

Synthes