Events

Recall of Teflon Tube T2 Humerus, Sterile (Intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires for nail insertion)

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-2013-RN-01151-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01151-1
  • 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
    Stryker has become aware that certain lots of the teflon tube have demonstrated a deficient seam in the sterile packaging. there is the potential for the inner pouch to be unsterile due to missing seal integrity.
  • Action
    Stryker is requesting hospitals to inspect their stock to determine if they have units from the affected lots. All affected product is to be returned to Stryker.

Device

Teflon Tube T2 Humerus, Sterile (Intended to support the exchange of the Ball Tip Guide Wires for...
  • Model / Serial
    Teflon Tube T2 Humerus, Sterile (Intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires for nail insertion)Catalogue Number: 18060073SLot Number: K0432D3ARTG Number: 139623
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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