BEUDAMED
    FDA Enforcement Class II Terminated

    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) 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-2084-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2084-2015
    Event ID
    69804
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Northern Digital Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    June 10, 2015
    Classification Date
    July 15, 2015
    Termination Date
    October 3, 2016
    Address
    103 Randall Drive, N/A, Waterloo, Ontario, N/A, Canada

    Description

    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) 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, may cause the two halves of the spheres to separate.

    Code Info

    1) Catalog Number: 41773 (90 pack) All Lots beginning with the prefix C / All expiration dates; 2) Catalog Number: 41774 (270 pack) All Lots beginning with the prefix C / All expiration dates; and 3) Catalog Number: 41813 (60 pack) All Lots beginning with the prefix C / All expiration dates

    Distribution

    US Nationwide Distribution

    Quantity

    524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 spheres and 41813 = 6,120 spheres)