BEUDAMED
    FDA Enforcement Class II Terminated

    Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal.

    Recall: Z-0765-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0765-2013
    Event ID
    64163
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    December 12, 2012
    Classification Date
    February 1, 2013
    Termination Date
    November 7, 2013
    Address
    1332 S Lone Hill Ave, N/A, Glendora, CA, 91740-5339, United States

    Description

    Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal.

    Reason

    The length markings on the Lightspeed LSX files were wrong.

    Code Info

    Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204.

    Distribution

    Worldwide Distribution - USA and the country of Canada.

    Quantity

    740 units