Events

Recall of PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences 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-00389-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00389-1
  • 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
    Incidents reported to the manufacturer, newdeal sas france, were attributed to the misalignment of the calcaneal or tibial screws and the panta arthrodesis nail, with or without clinical consequence during panta arthrodesis nail surgery. therefore, additional surgical precautions are being added to the surgical technique.
  • Action
    The manufacturer through Integra is revising the surgical technique to include additional precautions.

Device

PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail)
  • Model / Serial
    PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail)Catalogue number: 500-050, 500-080, 500-150, 500-180, 500-250, 500-280, 500-350, 500-380, 510-111, 510-141, 510-211, 510-241, 510-311, 510-341All batch numbers are affected. ARTG Number: 173962
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd