BEUDAMED
    FDA Recall 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 · Initiated August 7, 2017

    Recall

    Recall Number
    Z-3130-2017
    Event Number
    77950
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 7, 2017
    Terminated
    August 6, 2019
    Address
    2555 Davie Rd, Ste 110, Davie, FL, 33317-7424

    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.

    Action

    There will be no communication to the customer. Notification shall only go to the MAKO Product Specialist and Branch Managers as this action is not a customer facing issue. These letters and acknowledge forms were sent via Federal Express Two Days Air with return receipt.

    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)