Events

Recall of Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as part of the fixation system implantation kit)

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-2017-RN-00304-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00304-1
  • 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
    Johnson & johnson medical have received a complaint that the location slot for the screw holding sleeve was machined 3 mm out of position. the presence of a screwdriver, (part number 314.560) which is not manufactured to specification, may result in a surgical delay due to the non-conformance. the combination of the non-conforming screwdriver and a retaining sleeve will result in a situation where the surgeon will have minor difficulty interfacing the screw with the driver and sleeve, but the surgeon should still be able to insert the screw. it is important to note that the surgeon may opt to utilise the screwdriver without the retaining sleeve. the resulting surgical delay is not anticipated to be clinically significant (<15 minutes) and no additional intervention is anticipated.
  • Action
    Customers are advised to quarantine and return the affected stock in their possession to JJM.

Device

Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as...
  • Model / Serial
    Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as part of the fixation system implantation kit)Part Number: 314.560Lot Number: 7722501ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes