BEUDAMED
    FDA Recall Terminated

    Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    Recall: Z-0114-2010 · Initiated September 14, 2009

    Recall

    Recall Number
    Z-0114-2010
    Event Number
    53509
    Firm
    Synthes USA (HQ), Inc.
    FEI Number
    3005180112
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 14, 2009
    Posted
    November 9, 2009
    Terminated
    July 9, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.

    Reason

    loss of device height

    Action

    Synthes USA issued an "Urgent: Medical Device Recall" letter to hospital accounts, Synthes personal and sales consultants dated September 23, 2009. Users were asked to take inventory, complete and return a Verification form and return all affected product to the firm. For further information regarding the recall, contact Synthes at 1-800-479-6329 or 1-800-620-7025 extension 5453.

    Distribution

    Worldwide Distribution -- Including the United States and Canada.

    Quantity

    190 units