BEUDAMED
    FDA Enforcement Class II Terminated

    ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

    Recall: Z-0967-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0967-2013
    Event ID
    55155
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alphatec Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    July 6, 2011
    Classification Date
    March 18, 2013
    Termination Date
    March 20, 2013
    Address
    5818 El Camino Real, N/A, Carlsbad, CA, 92008-8816, United States

    Description

    ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.

    Reason

    The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.

    Code Info

    Lot # 635436; Part #73601-110

    Distribution

    Worldwide Distribution - USA including CO and NC; Internationally to Belgium.

    Quantity

    7