BEUDAMED
    FDA Enforcement Class II Terminated

    OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.

    Recall: Z-1717-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1717-2019
    Event ID
    82797
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OMNIlife science Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 12, 2019
    Initiation Date
    April 12, 2019
    Classification Date
    June 4, 2019
    Termination Date
    May 14, 2020
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085, United States

    Description

    OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System.

    Reason

    The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.

    Code Info

    MI1218

    Distribution

    US Nationwide distribution in the states of OK, SC, and WI.

    Quantity

    9