BEUDAMED
    FDA Recall Terminated

    Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. Intended to promote fusion of the cervical spine and occipitothoracic junction.

    Recall: Z-1144-2010 · Initiated February 2, 2010

    Recall

    Recall Number
    Z-1144-2010
    Event Number
    54507
    Firm
    Blackstone Medical, Inc.
    FEI Number
    3001238051
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 2, 2010
    Posted
    March 16, 2010
    Terminated
    April 9, 2010
    Address
    1211 Hamburg Tpke, Suite 300, Wayne, NJ, 07470

    Description

    Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. Intended to promote fusion of the cervical spine and occipitothoracic junction.

    Reason

    The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium.

    Action

    Orthofix Spinal Implants contacted customers by phone beginning December 22, 2009 and issued a Notification of Product Removal dated February 2, 2010. Consignees were instructed to Identify, Remove and Return all affected product to the firm. For further information, contact Orthofix Spinal Implants, Regulatory Affairs Department at 1-973-406-2812.

    Distribution

    Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.

    Quantity

    25