BEUDAMED
    FDA Enforcement Class II Terminated

    Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

    Recall: Z-3130-2017 · Reported September 20, 2017

    Enforcement

    Recall Number
    Z-3130-2017
    Event ID
    77950
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 20, 2017
    Initiation Date
    August 7, 2017
    Classification Date
    September 12, 2017
    Termination Date
    August 6, 2019
    Address
    2555 Davie Rd Ste 110, N/A, Davie, FL, 33317-7424, United States

    Description

    Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

    Reason

    Software discrepancy of not showing all the EE constants, when the screen is filled.

    Code Info

    All Lot codes

    Distribution

    Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey

    Quantity

    349 (US) and 78 (OUS)