BEUDAMED
    FDA Enforcement Class II Terminated

    MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

    Recall: Z-1411-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1411-2017
    Event ID
    76158
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    December 22, 2016
    Classification Date
    March 7, 2017
    Termination Date
    August 6, 2019
    Address
    2555 Davie Rd Ste 110, N/A, Davie, FL, 33317-7424, United States

    Description

    MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

    Reason

    Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

    Code Info

    Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #: 208692 - THA 2.1 Application User Guide Part Item #: 209711 - MAKOplasty THA Application User Guide Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide Part Item#: 212026 - THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1 Part Item # 204863 THA 1.0 Application User Guide Part Item # 207116 THA 2.0 Application User Guide Part Item # 208692 THA 2.1 Application User Guide Part Item # 209711 MAKOplasty THA Application User Guide Part Item # 210555 MAKIplast THA 3.1 Application User Guide Part Item # 212026 THA Application User Guide

    Distribution

    US nationwide distribution.

    Quantity

    777