BEUDAMED
    FDA Recall Terminated

    STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY

    Recall: Z-2573-2014 · Initiated September 10, 2012

    Recall

    Recall Number
    Z-2573-2014
    Event Number
    69033
    Firm
    PIONEER SURGICAL TECHNOLOGY, INC.
    FEI Number
    1000115331
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 10, 2012
    Posted
    September 3, 2014
    Terminated
    September 30, 2014
    Address
    375 River Park Cir, Marquette, MI, 49855-1781

    Description

    STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY

    Reason

    Some set screw thread profiles were found not to be within specifications.

    Action

    The recall took place at the distributor/sales representative level. Communication was done through phone and email notifications on 9/10/2012. All affected set screws were to be traded out through a scheduled process. This was coordinated through Pioneer Surgical's customer service. Product was scrapped and no reconditioning took place. All affected set screws were swapped out.

    Distribution

    Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.

    Quantity

    11 sets