BEUDAMED
    FDA Recall Terminated

    Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60

    Recall: Z-1099-2007 · Initiated May 12, 2007

    Recall

    Recall Number
    Z-1099-2007
    Event Number
    37982
    Firm
    Power Medical Interventions, Inc
    FEI Number
    3003171713
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 12, 2007
    Posted
    July 24, 2007
    Terminated
    August 29, 2007
    Address
    2021 Cabot Blvd W, Langhorne, PA, 19047-1810

    Description

    Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60

    Reason

    Malfunction - improper staple formation

    Action

    The field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites.

    Distribution

    The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany

    Quantity

    9 units