BEUDAMED
    FDA Recall Terminated

    Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished)

    Recall: Z-0375-2007 · Initiated December 27, 2006

    Recall

    Recall Number
    Z-0375-2007
    Event Number
    36922
    Firm
    Davol, Inc., Sub. C. R. Bard, Inc.
    FEI Number
    1213643
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 27, 2006
    Posted
    February 1, 2007
    Terminated
    July 6, 2016
    Address
    100 Sockanossett Crossroad, Cranston, RI, 02920

    Description

    Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished)

    Reason

    Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing

    Action

    Davol notified users by a first letter on 12/27/06 providng a introductory letter explaining the Enhanced Servicing Program and changes made to the IFU (re: servicing, tip inspection, end of wire, and test fire protocol). A second letter will issue to accounts to identifying the serial number to be serviced and returned to Davol.

    Distribution

    Worldwide, including USA, Austria, Italy, Israel, Finland, Switzerland, Portugal, Japan, France, Spain, Greece, Belgium, Germany, Sweden, Holland, Denmark, UK, and South Africa.

    Quantity

    4787 (includes both types)