BEUDAMED
    FDA Recall 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 · Initiated October 5, 2016

    Recall

    Recall Number
    Z-0592-2017
    Event Number
    75337
    Firm
    Alphatec Spine, Inc. 5830 El Camino Real
    FEI Number
    2027467
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 5, 2016
    Posted
    November 16, 2016
    Terminated
    February 17, 2017
    Address
    Carlsbad, CA, 92008-8816

    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.

    Action

    Alphatae Spine sent an Urgent Medical Device Recall notification letter dated September 29, 2016 to customers. The letter identified the affected product, problem and the actions to be taken. Customers are instructed to fill out and return the last page of recall letter using one of the methods identified in the letter.

    Distribution

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

    Quantity

    16,972 units