BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2093-2015 · Initiated May 20, 2015

    Recall

    Recall Number
    Z-2093-2015
    Event Number
    71350
    Firm
    Northern Digital Inc. 103 Randall Drive Waterloo Canada Ontario
    FEI Number
    3002743211
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 20, 2015
    Posted
    July 16, 2015
    Terminated
    October 13, 2017

    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.

    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 [email protected].

    Distribution

    Worldwide - US Nationwide Distribution and the countries of Australia and Canada.

    Quantity

    32,400 spheres