BEUDAMED
    FDA Recall 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 · Initiated June 10, 2015

    Recall

    Recall Number
    Z-2084-2015
    Event Number
    69804
    Firm
    Northern Digital Inc. 103 Randall Drive Waterloo Canada Ontario
    FEI Number
    3002743211
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 10, 2015
    Posted
    July 16, 2015
    Terminated
    October 3, 2016

    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.

    Action

    NDI sent an Urgent Customer Notification letter dated June 10, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Acknowledgement Form attached to the notification letter and return using the enclosed pre-paid FedEx label. For questions, contact NDI at 1 (877) 634-6340 ext. 544 (if calling from North America) or +1 (800) 634 634 00 ext. 544 (if calling from outside North America) .

    Distribution

    US Nationwide Distribution

    Quantity

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