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    Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF: PC2-400155; Navigation, 3.5mm Tap, REF: PC2-400235; Navigation, 4.0mm Tap, REF: PC2-400240; Navigation, 4.5mm Tap, REF: PC2-400245; Navigation, 4.5mm Dual Lead Tap, REF: PC2-400345; Navigation, 5.5mm Dual Lead Tap, REF: PC2-400355

    FDA Recall
    Open, Classified ·SEASPINE ORTHOPEDICS CORPORATION·Product code OLO·November 17, 2025

    Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In combination with a tera-tracker reference frame, is used by an Orthopedic surgeon to navigate the location of an acetabular cup positioner/impactor during hip replacement surgery.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code HAW·November 3, 2009

    Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable handheld instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·February 6, 2012

    Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·February 6, 2012

    Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code HAW·January 20, 2011

    Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code HAW·January 20, 2011

    Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code JZL·October 17, 2007

    Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code HAW·December 22, 2010

    Medtronic Navigation O-arm 02 surgical x-ray imaging system

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OWB·March 17, 2016

    The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·November 13, 2012

    UPGRD PRGM 9734638 ADD AxiEM NAVIGATION

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014

    StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·July 15, 2013

    Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OWB·September 22, 2016

    Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code IZL·October 12, 2010

    Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code OXO·January 31, 2013

    StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·June 5, 2020

    Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code HAW·May 10, 2017

    Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027

    FDA Recall
    Terminated ·Medtronic Navigation, Inc·Product code IZL·November 27, 2007

    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.

    FDA Recall
    Open, Classified ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code OLO·January 2, 2026

    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.

    FDA Recall
    Open, Classified ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code OLO·January 2, 2026