BEUDAMED
    FDA Enforcement Class II Terminated

    Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.

    Recall: Z-0412-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0412-2013
    Event ID
    63144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    August 28, 2012
    Classification Date
    November 21, 2012
    Termination Date
    June 11, 2015
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.

    Reason

    Inspan Compressors may break at weld causing a loss of compression

    Code Info

    Lot Numbers: SFP02323, SFP02323R, and SFP02323RR

    Distribution

    Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.

    Quantity

    17 units