BEUDAMED
    FDA Recall 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 · Initiated December 12, 2012

    Recall

    Recall Number
    Z-0765-2013
    Event Number
    64163
    Firm
    Ormco/Sybronendo
    FEI Number
    2016150
    Product Code
    EKS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 12, 2012
    Posted
    February 1, 2013
    Terminated
    November 7, 2013
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    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.

    Action

    Sybron Endo sent a Urgent: Medical Device Recall letter dated December 21, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has come to our attention that the length rings laser-etched on several lots of the Lightspeed LSX Files are inaccurate. We are asking for the product to be returned since use of the file could be a safety risk due to misadjustment of the file length. Please contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement.

    Distribution

    Worldwide Distribution - USA and the country of Canada.

    Quantity

    740 units