BEUDAMED
    FDA Recall Terminated

    NavLock Tracker *** Rx Only

    Recall: Z-1693-2020 · Initiated August 28, 2019

    Recall

    Recall Number
    Z-1693-2020
    Event Number
    85318
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 28, 2019
    Posted
    April 10, 2020
    Terminated
    May 5, 2021
    Address
    826 Coal Creek Cir, Louisville, CO, 80027-9710

    Description

    NavLock Tracker *** Rx Only

    Reason

    Product was incorrectly assembled which could affect navigation accuracy of the device.

    Action

    On 08/28/2019, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to its customer informing them of the manufacturing issue (incorrect assembly) and instructed them to: 1. Examine their inventory, and immediately quarantine the affected NavLock" Tracker and to return to the Recalling Firm. 2. To contact the Recalling Firm at 1-888-826-5603 to receive a return material authorization (RMA) and to arrange for return and a no-charge replacement. Once an RMA number is obtained, ship the affected product to Medtronic Product Services, 1480 Arthur Ave, Louisville CO 80027. 3. Follow instructions on the attached Customer Confirmation Form. Sign and date the bottom of the form and then return the form to [email protected] or fax it to Medtronic at 651-367-7075.

    Distribution

    U.S.: NY No O.U.S.

    Quantity

    1 unit