BEUDAMED
    FDA Recall Terminated

    Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.

    Recall: Z-0358-2009 · Initiated February 14, 2008

    Recall

    Recall Number
    Z-0358-2009
    Event Number
    46313
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    GFA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 14, 2008
    Posted
    December 2, 2008
    Terminated
    July 7, 2009
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.

    Reason

    The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.

    Action

    Consignees were notified via Urgent Medical Device Removal letter dated 2/14/08 to not use the device if it exhibited the problem, provided a response card, and stated that replacement motors will be shipped to the person listed on the returned response card.

    Distribution

    Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.

    Quantity

    69 total