Events

Recall of Integra CUSA Excel+ Sterile Torque Wrench, disposable

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Valleylab, a division of Tyco Healthcare Group LP.

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
    16388
  • Event Initiated Date
    2014-03-14
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Integra Neurosciences Pty Ltd (NZ), 5B Suite B, 331 Rosedale Road, Albany, Auckland 0632
  • Reason
    There is potential that some lots of 23khz sterile torque disposable wrenches contain wrenches that will only fit 36khz cusa hand piece tips. the green colour code and size printed on the wrenches are correct for a 23khz wrench, but the affected wrench size insert is smaller than it should be and will only fit a 36khz tip.
  • Action
    Product to be returned to supplier

Device

Integra CUSA Excel+ Sterile Torque Wrench, disposable

Manufacturer

Valleylab, a division of Tyco Healthcare Group LP
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NZMMDSA