Events

Recall of Aliquot Syringe Delivery System Kits (orthopaedic surgical kit, used to place injectable synthetic cortical bone void filler in weak or diminished bone)

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-00652-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00652-1
  • 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
    When removing the aliquot catheter from the needle during a vertebroplasty procedure, there have been reported cases of the catheter breaking. this has been attributed to bending the catheter during its retraction from the needle.
  • Action
    Stryker is providing end users with additional information and warnings to reduce the chance of the catheter breaking due to bending during retraction. The device instructions for use will be updated to reflect this information.

Device

Aliquot Syringe Delivery System Kits (orthopaedic surgical kit, used to place injectable syntheti...
  • Model / Serial
    Aliquot Syringe Delivery System Kits (orthopaedic surgical kit, used to place injectable synthetic cortical bone void filler in weak or diminished bone)Catalogue number: 20900501Lot numbers: A1203024, A1205018, A1206005, A1109035ARTG Number: 140434
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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