Events

Recall of CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)

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-2014-RN-00306-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00306-1
  • 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
    Integra lifesciences has identified that some lots of 23 khz sterile torque wrenches contain wrenches that will only fit 36 khz cusa handpiece tips. the green colour code and size printed on the wrenches are correct for a 23 khz wrench, but the affected wrench size insert is smaller than it should be and will only fit a 36 khz cusa tip.
  • Action
    Integra is requesting end users to determine if they have any units from the affected lot. If the outer box has a green dot sticker the torque wrench can be used. If the box does not have a green dot sticker end users are requested to quarantine the unit. An Integra sales representative will arrange for the affected units to be inspected. In the event that an inspection cannot be undertaken in a reasonable time replacement units will be arranged.

Device

CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)
  • Model / Serial
    CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)Catalogue Number: C5601Lot Numbers: 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873, 1135014ARTG Number: 151 502
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd