Events

Recall of W & H Foot Control - S-N1/S-N2

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by A-DEC Australia.

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-2018-RN-00006-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00006-1
  • 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
    A-dec has been made aware of a potential malfunction with certain w&h; foot controls. the foot control might not switch back to zero position when the pedal is released. consequently, the motor keeps rotating. if this happens during automatic thread cutting or automatic screwing-in of implants, it can, in the worst case, lead to a serious injury of the patient. so far, no incident has been reported.
  • Action
    A-Dec will contact affected customers to arrange replacement foot controls to be provided. In the interim, the affected products must not be used for thread cutting and screwing in of implants. These operations have to be conducted manually.

Device

W & H Foot Control - S-N1/S-N2
  • Model / Serial
    W & H Foot Control - S-N1/S-N2Multiple Affected Serial NumbersARTG 125363 (ADEC AUSTRALIA - Implantmed (various models) - Drill/saw system, dental)
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA