Events

Recall of Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correction of congenital deficiencies or post-traumatic defects)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00806-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00806-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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 procedure, a 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.
  • Action
    Johnson & Johnson Medical is advising users to inspect stock and quarantine any remaining product for return. This action has been closed-out on 30/01/2017.

Device

Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correctio...
  • Model / Serial
    Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correction of congenital deficiencies or post-traumatic defects)Part Numbers: 487.962, 487.963, 487.964, 487.965, 487.974, 487.975All lots affectedARTG Number: 183673
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes