BEUDAMED
    FDA Recall 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 · Initiated April 12, 2019

    Recall

    Recall Number
    Z-1717-2019
    Event Number
    82797
    Firm
    OMNIlife science Inc.
    FEI Number
    3008342029
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 12, 2019
    Terminated
    May 14, 2020
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085

    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.

    Action

    On April 12, 2019, the firm notified customers of the recall through phone, email, and federal mailing titled URGENT MEDICAL DEVICE ADVISORY NOTICE. Customers were informed that the locking mechanism on the iBlock Cutting Guide may loosen during use. Customers were asked to: -Immediately quarantine lot MI1218 -Return product to the firm -Acknowledge receipt of the notice be completing and returning the Receipt form by fax or email. The firm's investigation is ongoing. For further information contact Christina Rovaldi, Sr. Regulatory Affairs Specialist at 774- 226-1847 or 800-448-6664. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.

    Distribution

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

    Quantity

    9