BEUDAMED
    FDA Enforcement Class II 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 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0224-2016
    Event ID
    72224
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 11, 2015
    Initiation Date
    July 16, 2015
    Classification Date
    November 5, 2015
    Termination Date
    December 14, 2016
    Address
    2555 Davie Rd Ste 110, N/A, Plantation, FL, 33317-7424, United States

    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.

    Code Info

    Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.

    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