BEUDAMED
    FDA Recall Terminated

    SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue

    Recall: Z-2047-2014 · Initiated June 2, 2014

    Recall

    Recall Number
    Z-2047-2014
    Event Number
    68565
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    June 2, 2014
    Posted
    July 14, 2014
    Terminated
    September 15, 2017
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue

    Reason

    Sterility of device is compromised due to breach in sterile barrier

    Action

    Smith & Nephew issued an Urgent - Product Recall Notification letter dated June 2, 2014 via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and locate all affected product and quarantine them immediately. Complete the Return Certification Form . Contact the Smith & Nephew Returns Group at 800-343-5717 (option 3) or send an email to [email protected]. They will provide customers with instructions for returning their product and receiving a replacement. For questions regardin g this recall call 978-749-1073.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.

    Quantity

    907 units