BEUDAMED
    FDA Recall Terminated

    RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210272

    Recall: Z-0664-2007 · Initiated January 19, 2007

    Recall

    Recall Number
    Z-0664-2007
    Event Number
    37232
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    GXI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 19, 2007
    Posted
    March 29, 2007
    Terminated
    January 18, 2008
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210272

    Reason

    Product is non-sterile but labeled incorrectly as sterile.

    Action

    Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007

    Distribution

    Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa.

    Quantity

    103 units