BEUDAMED
    FDA Recall Terminated

    Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)

    Recall: Z-0419-03 · Initiated November 11, 2002

    Recall

    Recall Number
    Z-0419-03
    Event Number
    25019
    Firm
    Medtronics Midas Rex
    FEI Number
    1625507
    Product Code
    HBB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 11, 2002
    Posted
    January 9, 2003
    Terminated
    March 21, 2003
    Address
    4620 North Beach Street, Fort Worth, TX, 76137

    Description

    Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)

    Reason

    Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.

    Action

    Recall letter was sent on 11/11/2002 to all consignees requesting that the consignee contact the Medtronic Neurologic Technologies sales representative for replacement.

    Distribution

    Nationwide: CA, OH, FL, PA, GA, AZ, LA, MI, TX, NJ, NM, NC, VA, WA, NE, AL, NY, TN

    Quantity

    PA100-94 cs, PM100-71ea, PM110-5 ea, PM200-24 ea