BEUDAMED
    FDA Enforcement Class II 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 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2093-2015
    Event ID
    71350
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Northern Digital Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 22, 2015
    Initiation Date
    May 20, 2015
    Classification Date
    July 16, 2015
    Termination Date
    October 13, 2017
    Address
    103 Randall Drive, N/A, Waterloo, Ontario, N/A, Canada

    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.

    Code Info

    1) Catalog Number: 41773 (90 pack) Lot # C102061501

    Distribution

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

    Quantity

    32,400 spheres