BEUDAMED
    FDA Recall Terminated

    Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS, Cestas France. Distributed by Stryker Spine, Allendale, NJ 07401-1677. The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.

    Recall: Z-1612-2009 · Initiated April 30, 2009

    Recall

    Recall Number
    Z-1612-2009
    Event Number
    52090
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    MNH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 30, 2009
    Posted
    July 7, 2009
    Terminated
    January 23, 2013
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS, Cestas France. Distributed by Stryker Spine, Allendale, NJ 07401-1677. The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.

    Reason

    The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.

    Action

    Stryker Spine issued an "Urgent Product Recall" notification dated April 29, 2009 via Federal Express to all Consignees. Users were instructed to quarantine all affected product and fax a copy of the Product Accountability Form to 201-760-8406. A Stryker sales representative will retrieve the quarantined product. For further information, contact Stryker Spine at 201-760-8206.

    Distribution

    Nationwide Distribution.

    Quantity

    387 in US