BEUDAMED
    FDA Enforcement Class II Terminated

    Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.

    Recall: Z-1559-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1559-2020
    Event ID
    85016
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intellijoint Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 1, 2020
    Initiation Date
    February 11, 2020
    Classification Date
    March 23, 2020
    Termination Date
    June 10, 2020
    Address
    60 Bathurst Dr Unit 1, N/A, Waterloo, N/A, N/A, Canada

    Description

    Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.

    Reason

    During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.

    Code Info

    Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.

    Quantity

    N/A