BEUDAMED
    FDA Recall Terminated

    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.

    Recall: Z-0944-2013 · Initiated February 7, 2013

    Recall

    Recall Number
    Z-0944-2013
    Event Number
    64342
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    JDS
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 7, 2013
    Posted
    March 13, 2013
    Terminated
    January 11, 2016
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.

    Reason

    75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.

    Action

    Smith & Nephew sales representatives and Smith & Nephew international distributors were notified of problem and the recall via email on February 7, 2013. They were instructed to cease use and distribution of the product and quarantine for return. Non responding consignees were notified again on February 28, 2013 by email. Hospitals were notified by letter beginning on February 7, 2013. Smith & Nephew also contacted the surgeons who implanted the screws by letter the week of February 11th. For questions regarding this recall call 978-749-1330.

    Distribution

    Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile.

    Quantity

    90 units