Events

Recall of RF MULTIGEN SYSTEM - RADIOFREQUENCY GENERATOR

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
    15878
  • Event Risk Class
    III
  • Event Initiated Date
    2016-10-13
  • 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
    The stryker rf multigen generator is part of the interventional spine (ivs) portfolio. the stryker rf multigen in combination with the stryker rf electrodes cables and cannulae are intended for coagulation of soft tissues in orthopedic spinal and neurosurgical applications. during testing it was found that incorrect information regarding sterilization for the multigen cables is listed in the care instructions and/or ifu packaged with the stryker rf multigen generator. the care instructions explain information regarding the cleaning and sterilization of the rf multigen system including the cables. previously distributed care instructions/instructions for use incorrectly contained instructions supporting the sterilization of the multigen cables.

Device

RF MULTIGEN SYSTEM - RADIOFREQUENCY GENERATOR
  • Model / Serial
    Model Catalog: 406-900-000 (Lot serial: LES6617); Model Catalog: 406-900-000 (Lot serial: LES896); Model Catalog: 406-900-000 (Lot serial: LES6167); Model Catalog: 406-900-000 (Lot serial: LES6360); Model Catalog: 406-900-000 (Lot serial: LES7061); Model Catalog: 406-900-000 (Lot serial: LES7130); Model Catalog: 406-900-000 (Lot serial: LES8400); Model Catalog: 406-900-000 (Lot serial: LES635); Model Catalog: 406-900-000 (Lot serial: LES797); Model Catalog: 406-900-000 (Lot serial: LES8189); Model Catalog: 406-900-000 (Lot serial: LES6905)
  • Product Description
    RF Multigen System- Radiofrequency generator
  • Manufacturer
    STRYKER CANADA (LP)

Manufacturer

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