BEUDAMED
    FDA Enforcement Class II Terminated

    Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.

    Recall: Z-1128-2015 · Reported February 25, 2015

    Enforcement

    Recall Number
    Z-1128-2015
    Event ID
    70374
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2015
    Initiation Date
    January 22, 2015
    Classification Date
    February 19, 2015
    Termination Date
    December 14, 2016
    Address
    2555 Davie Rd Ste 110, Plantation, FL, 33317-7424, United States

    Description

    Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.

    Reason

    When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated

    Code Info

    All lots, Part Numbers: 201000, 203999, 207300, and 209930.

    Distribution

    Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.

    Quantity

    228 units