BEUDAMED
    FDA Recall Terminated

    Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070

    Recall: Z-0953-04 · Initiated January 29, 2004

    Recall

    Recall Number
    Z-0953-04
    Event Number
    28980
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    GFF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 29, 2004
    Posted
    July 20, 2004
    Terminated
    May 3, 2012
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070

    Reason

    The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees.

    Action

    A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products.

    Distribution

    Products were distributed to 23 hospitals and surgical centers in NC, NB, IN, UT, TX, NY, WI, MO, TN, ID, OK, FL, MA, WY, NJ, LA.

    Quantity

    8 boxes 3 burs per box