Events

Recall of Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport

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-00531-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00531-1
  • 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 found that there is the potential for loosening of the safety clips from the intended position on the quick release mechanism of the transport struts. in the case of no safety clip and/or overloading, the frame may loosen, bend or break in time, causing frame stability collapse.
  • Action
    Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate return of the product and provide credit. Clinicians are advised to inspect if the Safety Clips are still in place when patients come in for routine follow up examination and replace the Safety Clips, and to consider contacting patients that do not show up for routine follow up examination. The need to replace the entire Hoffmann LRF Bone Transport if indicated should also be considered.

Device

Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport
  • Model / Serial
    Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone TransportItem Number: 49330401 Lot Numbers: J49236, V07241, V30655, V47575, V49404 ARTG Number: 258035
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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