BEUDAMED
    FDA Recall Terminated

    ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually.

    Recall: Z-0179-2007 · Initiated December 20, 2005

    Recall

    Recall Number
    Z-0179-2007
    Event Number
    34438
    Firm
    Linvatec Corp.
    FEI Number
    1017294
    Product Code
    KFK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2005
    Posted
    November 16, 2006
    Terminated
    July 11, 2012
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually.

    Reason

    The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. The nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations.

    Action

    Linvatec will send each consignee a recall package that will include: a 12/20/2005 recall letter and reply form, A product correction instruction sheet , a new Sternum Saw Collet Nut and an assembly manual. Linvatec will also contact each consignee by phone or email. All consignees that have not responded by 30 days after the first mailing will be re-contacted by the firm by mail, phone or email.

    Distribution

    Worldwide, including USA, Mexico, and Canada.

    Quantity

    11424 units