BEUDAMED
    FDA Enforcement Class II Terminated

    TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.

    Recall: Z-1637-2014 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1637-2014
    Event ID
    68043
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 28, 2014
    Initiation Date
    April 4, 2014
    Classification Date
    May 20, 2014
    Termination Date
    July 1, 2017
    Address
    1450 E. Brooks Rd, N/A, Memphis, TN, 38116, United States

    Description

    TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.

    Reason

    A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

    Code Info

    (1) REF 71676515, Lot Number 13LT36602 (2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 14AT38714 (3) REF 71676558, Lot Numbers: 13KT36282, 13MT37356, 13MT37664, 13MT37949, 14AT38187 (4) REF 71676561, Lot Numbers: 13LT36605, 13MT37358, 14AT38188

    Distribution

    Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.

    Quantity

    1,253 units total