Events

Recall of Teflon Tube T2 Humerus, Sterile

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-2015-RN-00438-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00438-1
  • 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
    During a shelf life study, it was found that particular lots of product failed a dye penetration test demonstrating a deficient seam in the sterile packaging. the seams of the pouches made by one supplier were confirmed to be within specification and do not exhibit any non-conformance. the in-house made cross seam was confirmed to be manufactured out of specification. thus these lots have been deemed as having potentially insufficient packaging integrity and therefore regarded to be unsterile.
  • Action
    Stryker is notifying surgeons of the issue and provided advice on patient follow up. This action has been closed-out on 04/05/2017

Device

Teflon Tube T2 Humerus, Sterile
  • Model / Serial
    Teflon Tube T2 Humerus, SterileCatalogue Number: 18060073SLot Number: K0432D3ARTG Number: 139623
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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