Recall of Instructions For Use (IFU) - Sonopet Ultrasonic Products

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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    The fda has recommended that device manufacturers add the following statement to product labelling for ultrasonic aspirators indicated for laparoscopic, open, or gynaecologic surgery:"contraindication: this ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids."given this, stryker is updating the ifu to include this for all sonopet ultrasonic products. all sonopet ultrasonic products manufactured after march 30, 2018 will include an already updated ifu.
  • Action
    Stryker is advising customers that the current IFU is being updated to reflect the new contraindications. Users are to maintain awareness of the updated contraindication to ensure the device is not used for fragmentation, emulsification, and aspiration of uterine fibroids.


  • Model / Serial
    Instructions For Use (IFU) - Sonopet Ultrasonic ProductsMultiple affected productsARTG numbers:174349 (Stryker Australia - Electrosurgical unit, ultrasonic/mechanical vibration)297743 (Stryker Australia Pty Ltd - Ultrasonic surgical system torque wrench, reusable)298249 (Stryker Australia - Electrode handpiece, electrosurgical, ultrasonic/mechanical vibration, foot-controlled)
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source