BEUDAMED
    FDA Enforcement Class II Terminated

    Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).

    Recall: Z-0592-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0592-2017
    Event ID
    75337
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alphatec Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2016
    Initiation Date
    October 5, 2016
    Classification Date
    November 16, 2016
    Termination Date
    February 17, 2017
    Address
    5830 El Camino Real, N/A, Carlsbad, CA, 92008-8816, United States

    Description

    Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).

    Reason

    Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.

    Code Info

    Lot Numbers 695621 696252 697128 698437 700943 7689801 695622 696253 697129 698438 700944 7689802 695623 696254 697130 698439 700945 7689803 695624 696255 697131 698440 701393 7689804 695625 696256 697520 698441 701394 695626 696257 697521 698442 701395 695627 696258 697522 700611 701396 696124 696558 697523 700612 701397 696125 696574 697524 700613 701398 696126 696575 698433 700614 701399 696127 696576 698434 700615 701400 696128 696577 698435 700941 701401 696251 697127 698436 700942 701851 7878901 7829602 7766302 7766301

    Distribution

    Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.

    Quantity

    16,972 units