Events

Recall of NDI DISPOSABLE REFLECTIVE MARKER SPHERE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NORTHERN DIGITAL 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
    20776
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-21
  • 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
    On april 30 2015 ndi received a complaint from a customer reporting that a drms sphere fell apart while the patient's leg was being aligned with the navigation system during a total knee replacement surgery... based on the reported complaint ndi promptly instituted a stop ship order... then performed a recall of the affected lot... further investigation has identified a similar failure mode with different root causes that has occurred at a significantly lower rate in additional lots of the product.

Device

NDI DISPOSABLE REFLECTIVE MARKER SPHERE
  • Model / Serial
    Model Catalog: 41773 (Lot serial: C106861402); Model Catalog: 41773 (Lot serial: C103091402); Model Catalog: 41773 (Lot serial: C102811402); Model Catalog: 41773 (Lot serial: C100641501); Model Catalog: 41773 (Lot serial: C101791401); Model Catalog: 41773 (Lot serial: C101021501); Model Catalog: 41773 (Lot serial: C100641502); Model Catalog: 41773 (Lot serial: C102581402)
  • Product Description
    NDI DISPOSABLE REFLECTIVE MARKER SPHERE
  • Manufacturer
    NORTHERN DIGITAL INC.

Manufacturer

NORTHERN DIGITAL INC.