BEUDAMED
    FDA Recall 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 · Initiated August 28, 2012

    Recall

    Recall Number
    Z-0412-2013
    Event Number
    63144
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 28, 2012
    Posted
    November 21, 2012
    Terminated
    June 11, 2015
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    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

    Action

    Spine Frontier issued e-mail notices to customers on May 14, 2012 advising of the potential for breakage. Units were replaced with weld free design.

    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