BEUDAMED
    FDA Enforcement Class II Terminated

    SmartTools Knee System Orthopedic Stereotaxic Instrument

    Recall: Z-1868-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1868-2017
    Event ID
    76508
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthosoft, Inc. dba Zimmer CAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    February 20, 2017
    Classification Date
    April 19, 2017
    Termination Date
    September 18, 2017
    Address
    75 Queen St #3300, N/A, Montreal, N/A, N/A, Canada

    Description

    SmartTools Knee System Orthopedic Stereotaxic Instrument

    Reason

    There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P

    Code Info

    Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711

    Distribution

    Nationwide Distribution

    Quantity

    84