BEUDAMED
    FDA Recall 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 · Initiated February 11, 2020

    Recall

    Recall Number
    Z-1559-2020
    Event Number
    85016
    Firm
    Intellijoint Surgical, Inc.
    FEI Number
    3010822102
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 11, 2020
    Terminated
    June 10, 2020
    Address
    60 Bathurst Dr, Unit 1, Waterloo 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.

    Action

    The firm notified the Intellijoint Surgical Sales Representatives that manage the affected sites. Communications were sent via email on 2/11/2020. Sales reps are responsible for verbally communicating the correction to affected users within their respective service areas. Users were to be advised of the following: (1) Until a Software update is provided, users should consult the Instructions for Use (Section 6.9.4 Lateral Femoral Condyle Definition (pg. 42) and Section 6.9.5 Medial Femoral Condyle Definition (pg. 42)) and follow the steps outlined for the acquisition of data used to calculate resection depth. (2) Resection depth should be verified by manual methods (calipers, angel wings etc.) for each case. (3) Due to the low risk and nature of the error, Intellijoint is not requesting that affected product be returned unless requested by the customer. Should the customer/user wish to return affected devices, please contact Sankavi Muralitharan ([email protected]) or Breanne Cuddington, Senior Regulatory Affairs Associate, at [email protected]; 1-888-232-2634 ex. 2234. A software update is under development to correct for this error. The expected release date for the update is February 29, 2020, at which time Intellijoint Sales Representatives will update all affected systems with the new software by March 30, 2020.

    Distribution

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