BEUDAMED
    FDA Recall Terminated

    Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas

    Recall: Z-0977-04 · Initiated December 16, 2003

    Recall

    Recall Number
    Z-0977-04
    Event Number
    29132
    Firm
    Mentor Texas, Inc
    FEI Number
    1000118360
    Product Code
    FTN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2003
    Posted
    July 20, 2004
    Terminated
    May 25, 2004
    Address
    3041 Skyway Cir N, Irving, TX, 75038-3500

    Description

    Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas

    Reason

    Device was distributed without the dome part accessory, part number 350-DOMPK

    Action

    The recall letters for Lot 269402 were sent on 12/16/2003. The recall letters for Lot 264358 were sent on 02/06/2004. Each letter included 5 dome pack accessories as a temporary corrective action.

    Distribution

    Nationwide. Recalled product was shipped domestically to accounts in AZ, AR, CA, GA, IL, IN, KY, MD, MI, OH, OK, OR, TX, and NY. There was no foreign distribution.

    Quantity

    51 units