BEUDAMED
    FDA Recall Terminated

    SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).

    Recall: Z-1049-03 · Initiated June 30, 2003

    Recall

    Recall Number
    Z-1049-03
    Event Number
    26617
    Firm
    Power Medical Interventions
    FEI Number
    3003171713
    Product Code
    GAG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2003
    Posted
    July 24, 2003
    Terminated
    March 16, 2004
    Address
    110 Union Square Drive, New Hope, PA, 18938

    Description

    SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).

    Reason

    latching mechanism failure

    Action

    The recalling firm issued a recall letter dated 6/30/03 to their accounts informing them of the recall and the need to return the product.

    Distribution

    The products were shipped to medical facilities and sales representatives nationwide. The products were also shipped to distributors in Belgium, Germany, Ireland, Israel, Italy, Japan, Netherlands, and Spain

    Quantity

    767 units