BEUDAMED
    FDA Enforcement Class II Terminated

    TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery

    Recall: Z-1132-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1132-2013
    Event ID
    64669
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 24, 2013
    Initiation Date
    March 6, 2013
    Classification Date
    April 17, 2013
    Termination Date
    August 16, 2019
    Address
    1450 E. Brooks Rd, N/A, Memphis, TN, 38116, United States

    Description

    TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery

    Reason

    One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).

    Code Info

    Lot Number 12FM12182

    Distribution

    Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.

    Quantity

    23 units