BEUDAMED
    FDA Enforcement Class III Terminated

    OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty

    Recall: Z-0610-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0610-2017
    Event ID
    75499
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    OMNI LIFE SCIENCE
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 23, 2016
    Initiation Date
    October 14, 2016
    Classification Date
    November 17, 2016
    Termination Date
    February 1, 2017
    Address
    480 Paramount Dr, N/A, Raynham, MA, 02767-1085, United States

    Description

    OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty

    Reason

    Incorrect lot number on outer kit

    Code Info

    Lot number: 19-09-021

    Distribution

    Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.

    Quantity

    15 units