BEUDAMED
    FDA Enforcement Class II Terminated

    smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument

    Recall: Z-3100-2017 · Reported September 6, 2017

    Enforcement

    Recall Number
    Z-3100-2017
    Event ID
    77827
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2017
    Initiation Date
    July 24, 2017
    Classification Date
    August 29, 2017
    Termination Date
    August 21, 2020
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument

    Reason

    The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.

    Code Info

    Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948

    Distribution

    Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.

    Quantity

    402 units