Events

Recall of Guide Wires and K-Wires for T2 and Gamma Nailing Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2016-RN-00002-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00002-2
  • 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
    It has been discovered that the seal integrity of the pouch may be decreased. a potential capillary defect in the sealing could potentially lead to the product becoming unsterile, which could result in an infection. no injury or harm has been reported for this event so far.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Guide Wires and K-Wires for T2 and Gamma Nailing Systems
  • Model / Serial
    Guide Wires and K-Wires for T2 and Gamma Nailing SystemsCatalogue numbers: 01520218S,12106450,18060050S,18060080S,18060083S,18060084S, 18060085S, 18060090S, 18060093S, 18061250S, 18061417S, 18063030S, 18063031SMultiple Lot Numbers affectedARTG Number: 190236
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA