Events

Recall of Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steel

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-00235-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00235-1
  • 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 content of the packaging received may not match the label on the package. the label on the package may indicate a 1.5 mm cortex screw with stardrive recess, self-tapping, length 8 mm, part number 02.214.108 and lot number 9682574. however, the screw in the package may be a 1.5 mm locking screw with stardrive recess, self-tapping, length 8 mm, part number 02.214.008 and lot number 9674525. the difference between these two screws is that the locking screw has a threaded head profile while the cortex screw does not. if the incorrect screw is used, there may be a small surgical delay while a correct screw is located.
  • Action
    Johnson & Johnson Medical (JJM) is advising users to inspect and quarantine any affected stock and return to JJM. This action has been closed-out on 27/01/2017.

Device

Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, se...
  • Model / Serial
    Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steel Part Number: 02.214.108 Lot Number: 9682574Locking Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steelPart Number: 02.214.008Lot Number: 9674525 (This lot was not distributed in Australia)ARTG Number: 157068
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes