BEUDAMED
    FDA Recall Terminated

    Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983

    Recall: Z-1233-06 · Initiated June 19, 2006

    Recall

    Recall Number
    Z-1233-06
    Event Number
    35766
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 19, 2006
    Posted
    July 13, 2006
    Terminated
    January 10, 2008
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983

    Reason

    Sterility seal of the package tray may have gaps/voids compromising the sterility of the device.

    Action

    Smith & Nephew notified consignees by Certified letter dated 6/19/06. Accounts are requested to return product. Smith & Nephew expanded the recall on 8/2/5/06 by letter to include addtional lot numbers.

    Distribution

    Nationwide Foreign: Smith & Nephew Canada, Germany, France, Istanbul

    Quantity

    1833 boxes/Expanded Recall 1851 units