BEUDAMED
    FDA Recall Terminated

    Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.

    Recall: Z-2745-2016 · Initiated July 19, 2016

    Recall

    Recall Number
    Z-2745-2016
    Event Number
    74771
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1219602
    Product Code
    MAI
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    July 19, 2016
    Terminated
    July 10, 2018
    Address
    130 & 120 Forbes Blvd, Mansfield, MA, 02048

    Description

    Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.

    Reason

    Sterility compromised due to breach in sterile packaging

    Action

    Smith & Nephew issued recall letters via Federal Express on July 19, 2016 to the customers. Customers asked to inspect inventory and locate any unused devices, and quarantine immediately. Contact Smith & Nephews Field Actions Department via email at [email protected] or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return.

    Distribution

    Worldwide distribution. US nationwide, and the countries of: AU, AT, BE, CA, CH, CR, DB, DE, ES, FI, FR, GB, GR, IC, IL, IN, IT, MY, NL, NO, PL, PR, PT,SE, SG, TH, and ZA.

    Quantity

    34,065 units