BEUDAMED
    FDA Recall Terminated

    TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420581

    Recall: Z-2396-2021 · Initiated August 10, 2021

    Recall

    Recall Number
    Z-2396-2021
    Event Number
    88522
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    NJL
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    August 10, 2021
    Terminated
    May 17, 2023
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420581

    Reason

    Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.

    Action

    Depuy issued Urgent Medical Device Recall (Removal) Letter on 8/10/21. Letter states reson for recall, health risk and action take: 1. Examine your inventory immediately to determine if you have the subject lot and quarantine the product. DO NOT USE THE PRODUCT. The surgical plan associated with the cases in Table 1 should not be used with conventional instruments. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return/credits of any affected devices or contact TruMatch Personalized Solutions Customer Support at 1-800-689-0746 / [email protected] between 7am and 7pm EST. 3. Review, complete, sign, and return the attached business response form (page 4 of this letter) to [email protected] within 3 business days of receipt of this notification. Please include in the email subject: FA 2000415: 2021 - TruMatch Personalized Solutions 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the devices subject to this action). 5. If any of the subject lot has been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. This medical device product recall has been reported to health authorities. We apologize for the inconvenience that this recall may cause and appreciate your cooperation with our request. Should you have any inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.

    Distribution

    Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.

    Quantity

    2 cases (1 case)