BEUDAMED
    FDA Recall Terminated

    Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA Stryker Mantis Rod Inserter Inner Shaft Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA IS2097MAN Mantis Rod Inserter Shaft Used to facilitate insertion and delivery of a Mantis rod.

    Recall: Z-0175-2012 · Initiated June 24, 2011

    Recall

    Recall Number
    Z-0175-2012
    Event Number
    59996
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 24, 2011
    Posted
    November 8, 2011
    Terminated
    November 13, 2012
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA Stryker Mantis Rod Inserter Inner Shaft Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA IS2097MAN Mantis Rod Inserter Shaft Used to facilitate insertion and delivery of a Mantis rod.

    Reason

    There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter.

    Action

    Stryker notified branches/agencies, surgeons and hospitals beginning June 24, 2011 with an Urgent Product Recall letter, dated June 24, 2011, via Fed Ex. The letter identified the affected product, the issue, potential hazards, risk mitigations, and the return process. Customers were asked to examine their inventory and reconcile any inserters and shafts with the catalog numbers provided using the Customer Response Form. Customers are to fax the form to Regulatory Compliance at 201-760-8370 within 5 days of receipt of the letter. The affected product should be retrieved and returned. Questions should be directed to 201-760-8298.

    Distribution

    Nationwide Distribution

    Quantity

    471 units US, 667 units international