Events

Recall of SONOPET - UNIVERSAL HANDPIECE ANGLED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA 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
    133723
  • Event Risk Class
    III
  • Event Initiated Date
    2018-03-15
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    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. industry-wide ifu update initiated by the fda. adding the contraindication: this ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation emulsification and aspiration of uterine fibroids.

Device

SONOPET - UNIVERSAL HANDPIECE ANGLED
  • Model / Serial
    Model Catalog: 5450-820-000 (Lot serial: All); Model Catalog: 5450-840-000 (Lot serial: All); Model Catalog: 5450-850-000 (Lot serial: ALL)
  • Product Description
    Sonopet Universal;Sonopet Universal Handpiece;Sonopet Main Unit
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC