BEUDAMED
    FDA Enforcement Class II Terminated

    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.

    Recall: Z-0943-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0943-2013
    Event ID
    64342
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 20, 2013
    Initiation Date
    February 7, 2013
    Classification Date
    March 13, 2013
    Termination Date
    January 11, 2016
    Address
    1450 E. Brooks Rd, N/A, Memphis, TN, 38116, United States

    Description

    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 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.

    Code Info

    Batch Number 12KM01206

    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

    69 units