Events

Recall of Quadra Trial Broach size 0

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medacta Australia Pty Ltd.

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-2013-RN-00017-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00017-1
  • 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 manufacturer has advised that the tip of a quadra broach (size 0) broke in the intra-medullary channel while broaching, during a total hip replacement surgery.This recall action was carried out prior to approval of the recall strategy by the tga.
  • Action
    Medacta Australia is requesting users return affected devices to Medacta for replacement with unaffected product.

Device

Quadra Trial Broach size 0
  • Model / Serial
    Quadra Trial Broach size 0Lot numbers: 074696, 074878, 074879, 075022, 075023, 075056, 075064, 084000, 084001, 084326, 084409, 084743, 084753, 084815, 084816, 085202, 085318, 085455, 085690
  • Manufacturer
    Medacta Australia Pty Ltd

Manufacturer

Medacta Australia Pty Ltd