BEUDAMED
    FDA Recall Terminated

    SurgAssist System Circular Stapler DLU 33mm

    Recall: Z-0253-04 · Initiated November 20, 2003

    Recall

    Recall Number
    Z-0253-04
    Event Number
    27764
    Firm
    Power Medical Interventions
    FEI Number
    3003171713
    Product Code
    GWD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 20, 2003
    Posted
    December 19, 2003
    Terminated
    February 10, 2004
    Address
    110 Union Square Dr, New Hope, PA, 18938-1365

    Description

    SurgAssist System Circular Stapler DLU 33mm

    Reason

    improper staple formation or anvil jam

    Action

    On 11/20/03, the recalling firm sent recall notices via overnight carrier to all customers who have been shippped and/or sold the product. The recall notice requested the return of the devices.

    Distribution

    The products were shipped to medical facilities and sales representatives nationwide. The product was also shipped to distributors in the United Kingdom, France, Scotland, Belgium, Germany, Israel, Italy, Japan, Spain, Portugal, and Sweden.

    Quantity

    350 units