BEUDAMED
    FDA Recall Terminated

    Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, Sterile, Single Use Only.

    Recall: Z-1574-05 · Initiated September 1, 2005

    Recall

    Recall Number
    Z-1574-05
    Event Number
    33340
    Firm
    Power Surgical Solutions
    FEI Number
    1625507
    Product Code
    GET
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2005
    Posted
    September 21, 2005
    Terminated
    July 25, 2007
    Address
    4620 N Beach St, Fort Worth, TX, 76137-3219

    Description

    Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, Sterile, Single Use Only.

    Reason

    Potential compromise of sterile packaging for disposable dissecting tools.

    Action

    Firm notified consignees by letter on 9/1/2005.

    Distribution

    Nationwide and the following foreign countries: Aruba, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Mexico, Netherlands, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russia, S. Africa, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, U.S. Virgin Islands, Uae, United Kingdom, Uruguay, and Venezuela

    Quantity

    3,522,710 units