Events

Recall of EXOGEN 4000+ BONE HEALING SYSTEM - MAIN OPERATING UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITH & NEPHEW 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
    49030
  • Event Risk Class
    II
  • Event Initiated Date
    2009-06-10
  • 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
    A small percentage of the devices (approximately 1%) may deliver less than the intended amount of ultrasound. this reduction in ultrasound output is the result of partial loosening of internal glued components within the small black cylindrical head called a transducer. reduced ultrasound output may affect the progres of patient fracture healing.

Device

EXOGEN 4000+ BONE HEALING SYSTEM - MAIN OPERATING UNIT
  • Model / Serial
    Model Catalog: 71034101 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    EXOGEN BONE HEALING SYSTEM
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.