BEUDAMED
    FDA Recall Terminated

    ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

    Recall: Z-1822-2015 · Initiated April 30, 2015

    Recall

    Recall Number
    Z-1822-2015
    Event Number
    71257
    Firm
    Smith & Nephew, Inc.
    FEI Number
    3003604053
    Product Code
    GAT
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    April 30, 2015
    Posted
    June 22, 2015
    Terminated
    September 19, 2017
    Address
    150 Minuteman Rd, Andover, MA, 01810-1031

    Description

    ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

    Reason

    Sterility of device maybe compromised

    Action

    Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at [email protected] or fax +1-901-566-7975 to obtain a return authorization (RA) number

    Distribution

    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.

    Quantity

    202,279 units