BEUDAMED
    FDA Recall 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 · Initiated July 24, 2017

    Recall

    Recall Number
    Z-3100-2017
    Event Number
    77827
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 24, 2017
    Terminated
    August 21, 2020
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    Smith & Nephew sent an Urgent Medical Device Recall Notice dated July 24, 2017, to all affected consignees. The firm notified their consignees by email and Fed Ex on 07/24/2017. Consignees have been asked to inspect inventory to locate and quarantine affected product. All consignees were asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew. Customers with questions were instructed to contact [email protected]. For questions regarding this recall call 978-749-1440.

    Distribution

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

    Quantity

    402 units