Events

Recall of MORCELLEX SIGMA - GENERATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

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
    28623
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-01
  • 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
    Customers are being made aware that the us fda issued a safety communication on april 17 2014 discouraging the use of laparoscopic uterine power morcellation in hysterectomy or myomectomy in women with uterine fibroids because of the risk of spreading unsuspected cancerous tissue notably uterine sarcomas beyond the uterus. health care providers should carefully consider alternative treatment options for symptomatic uterine fibroids.

Device

MORCELLEX SIGMA - GENERATOR
  • Model / Serial
    Model Catalog: MD0200 (Lot serial: ALL LOTS); Model Catalog: DV0015 (Lot serial: ALL LOTS); Model Catalog: MX0200R (Lot serial: ALL LOTS); Model Catalog: MD0100 (Lot serial: ALL LOTS); Model Catalog: MD0120 (Lot serial: ALL LOTS); Model Catalog: MX0200 (Lot serial: ALL LOTS); Model Catalog: MX0100R (Lot serial: ALL LOTS); Model Catalog: MX0100 (Lot serial: ALL LOTS)
  • Product Description
    MORCELLEX SIGMA - GENERATOR
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.