Events

Recall of Stryker Medtech - IIb - 44750; Soft-tissue ultrasonic surgical system handpiece, foot controlled reusable

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Stryker Medtech K.K..

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
    22799
  • Event Initiated Date
    2018-04-11
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    Additional information is being added to the instructions for use (ifu) for sonopet® ultrasonic products. ultrasonic surgical aspirator devices use an oscillating tip to cause tissue fragmentation through the delivery of ultrasound energy to target tissue. the potential for tissue dissemination is mitigated, but not completely eliminated, by the use of suction/aspiration. although fda is not aware of reports of dissemination or upstaging of occult uterine malignancies related to ultrasonic surgical aspirators at this time, the agency is recommending that all device manufacturers add a contraindication against use for the removal of uterine fibroids.
  • Action
    Instructions for use to be updated

Device

Stryker Medtech - IIb - 44750; Soft-tissue ultrasonic surgical system handpiece, foot controlled ...
  • Model / Serial
    Model: , Affected: Small Long Angled Handpiece, Hyper Small Angled Handpiece
  • Manufacturer
    Stryker Medtech K.K.

Manufacturer

Stryker Medtech K.K.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA