BEUDAMED
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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

    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

    Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

    FDA Recall
    Open, Classified ·Product code OLO·July 17, 2024

    StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·August 22, 2024

    AxiEM" Non-Invasive Patient Tracker

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·December 15, 2022

    Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·March 26, 2024

    Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·November 11, 2021

    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code ONO·October 14, 2022

    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·April 11, 2023

    StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·September 27, 2023

    RadiaLux Lighted Retractor (Pink), REF: 50-101-1

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code GAD·December 8, 2022

    Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·December 4, 2024

    Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·November 28, 2023

    Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·April 11, 2023

    Mazor X Surgical System Positioner Type II, REF: ASM0214-02

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·December 5, 2019

    Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·November 28, 2023