Events

Recall of Attachment for Acetabular and Medullary Reaming (used with the Compact Air Drive II, an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery)

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-2015-RN-01094-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01094-1
  • 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 geometrical shape of a subcomponent of this attachment was inadvertently changed. this change allows potential unintended reverse (counter-clockwise) motion if the subcomponent is aligned in a specific orientation when the attachment is connected to the handpiece and both triggers are pressed.This attachment is intended to be used without reverse motion. unintentional activation in reverse could potentially damage flexible drilling or reaming shafts and could potentially cause serious injury to the patient.
  • Action
    Customer to return affected product. Sponsor to replace affected product. This action has been closed-out on 24/08/2016.

Device

Attachment for Acetabular and Medullary Reaming (used with the Compact Air Drive II, an air-drive...
  • Model / Serial
    Attachment for Acetabular and Medullary Reaming (used with the Compact Air Drive II, an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery)Product Number 511.785Serial Numbers: 16384,16385,16386,16387,16389,16390,16391,16392,16393, 16394,16395,16396,16397,16403,16405,1641ARTG Number: 157072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes