BEUDAMED
    FDA Recall Terminated

    5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.

    Recall: Z-1230-2007 · Initiated July 27, 2007

    Recall

    Recall Number
    Z-1230-2007
    Event Number
    38623
    Firm
    Mentor Texas, Inc
    FEI Number
    1000118360
    Product Code
    MUU
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 27, 2007
    Posted
    September 20, 2007
    Terminated
    April 4, 2008
    Address
    3041 Skyway Cir N, Irving, TX, 75038-3500

    Description

    5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.

    Reason

    Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530.

    Action

    Firm notified consignees by letter on July 27, 2007.

    Distribution

    Nationwide, including VA, IN, CA, and IL.

    Quantity

    4 units