Events

Recall of Omega+ Lag Screw Ø13X110MM ST

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-2017-RN-00526-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00526-1
  • 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 gmbh has received a customer complaint that the lag screw would not completely cannulate as the guide wire would not pass through the cannula of the screw. no harm was reported. it was found on investigation that the obstruction is related to a metal burr in the cannula of the screw which was not removed during manufacturing causing obstruction. the obstruction in the cannula of the screw is easily recognisable for the user. in most cases the surgeon would detect significant resistance when passing the lag screw over the guide wire before it touches the skin and would not continue using the screw. a different screw would be available and used, resulting in a minor delay in surgery of <15 minutes. if the surgeon does not notice or ignores the resistance, then surgical complications related to the guide wire being stuck in the cannulated screw and/or the guide wire being pushed out of the femoral head could theoretically occur.
  • Action
    Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate the return and replacement of the product.

Device

Omega+ Lag Screw Ø13X110MM ST
  • Model / Serial
    Omega+ Lag Screw Ø13X110MM STItem Number: 33625110Lot Number: V06279Ø13X105MM STItem Number: 33625105Lot Number: V06269ARTG Number: 119660
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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