BEUDAMED
    FDA Recall Terminated

    Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.

    Recall: Z-0224-2016 · Initiated July 16, 2015

    Recall

    Recall Number
    Z-0224-2016
    Event Number
    72224
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 16, 2015
    Posted
    November 5, 2015
    Terminated
    December 14, 2016
    Address
    2555 Davie Rd, Ste 110, Plantation, FL, 33317-7424

    Description

    Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.

    Reason

    The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

    Action

    As of July 16, 2015, Mako communicated by mail the nature of the recall to their Product Specialists and the OR Administrators describing the specifics regarding the issue for correction.

    Distribution

    Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.

    Quantity

    1,322 units