Events

Recall of Device Recall NDI Disposable Reflective Marker Spheres for Brainlab IGS system.

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    71350
  • Event Risk Class
    Class 2
  • Event Number
    Z-2093-2015
  • Event Initiated Date
    2015-05-20
  • Event Date Posted
    2015-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137384
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Neurological stereotaxic Instrument - Product Code HAW
  • Reason
    Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
  • Action
    NDI sent an Urgent Medical Device Recall letter dated May 20, 2015 to their customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. For question from Canada or the United States contact NDI at 1-877-634-6340 ext 544 and for outside North America call 1-800 634 634 00 ext 544. Customer Service can also be reached at spheres@ndigital.com.

Device

Device Recall NDI Disposable Reflective Marker Spheres for Brainlab IGS system.
  • Model / Serial
    1) Catalog Number: 41773 (90 pack) Lot # C102061501
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
  • Product Description
    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. || Product Usage: || Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
  • Manufacturer
    Northern Digital Inc.

Manufacturer

Northern Digital Inc.
  • Manufacturer Address
    Northern Digital Inc., 103 Randall Drive, Waterloo Canada Ontario
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA