BEUDAMED
    FDA Enforcement Class II Terminated

    L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

    Recall: Z-1461-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1461-2017
    Event ID
    76494
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kiscomedica S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    January 11, 2017
    Classification Date
    March 14, 2017
    Address
    Parc Technologique - 2 Place, Berthe Morisot, Saint Priest, N/A, N/A, France

    Description

    L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

    Reason

    Firm received a complaint of the tip holder breaking during use.

    Code Info

    Batch number: 15486

    Distribution

    Worldwide Distribution - US Nationwide in the states of MO and country of Switzerland.

    Quantity

    13 units