BEUDAMED
    FDA Recall Open, Classified

    AxiEM" Non-Invasive Patient Tracker

    Recall: Z-1039-2023 · Initiated December 15, 2022

    Recall

    Recall Number
    Z-1039-2023
    Event Number
    91354
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 15, 2022
    Posted
    January 30, 2023
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    AxiEM" Non-Invasive Patient Tracker

    Reason

    Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.

    Action

    On 12/15/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via mail courier informing customers is recalling two specific lots of AxiEM Non-Invasive Patient Trackers due to the potential for verification failure of navigation instruments during a Functional Endoscopic Sinus Surgery procedure. Customer are instructed: 1. Do NOT use any impacted product. Immediately locate and quarantine all unused impacted product(s). Refer to the affected lot numbers identified in Table 1 below. 2. Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. Their Medtronic Sales Representative can assist in initiating the return of the product as necessary. 3. Complete the Customer Confirmation Form enclosed with this letter (even if they have no product to return), acknowledging that they have received this information, and email the completed form to Medtronic at [email protected]. 4. If the affected devices have already been utilized and/or discarded, the firm is still asking that customers complete and return the Customer Confirmation Form detailing that information. For questions, contact Medtronic Sales Representative or Medtronic Technical Services at 1-888-826-5603 or via email at [email protected].

    Distribution

    Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The country of Japan.

    Quantity

    1,867 devies