BEUDAMED
    FDA Enforcement Class II Terminated

    MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.

    Recall: Z-2741-2017 · Reported July 26, 2017

    Enforcement

    Recall Number
    Z-2741-2017
    Event ID
    77553
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2017
    Initiation Date
    June 7, 2017
    Classification Date
    July 18, 2017
    Termination Date
    June 16, 2020
    Address
    2555 Davie Rd Ste 110, N/A, Davie, FL, 33317-7424, United States

    Description

    MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.

    Reason

    An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.

    Code Info

    Lot No. 05212015

    Distribution

    Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.

    Quantity

    20