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    Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10

    FDA Enforcement
    Class II ·Terminated·SIGHT DIAGNOSTICS LTD·September 29, 2021

    Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10

    FDA Recall
    Terminated ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·March 17, 2021

    Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code OLO·July 18, 2016

    MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·June 7, 2017

    Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code OLO·June 29, 2017

    Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code OLO·June 29, 2017

    ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code OLO·May 1, 2017

    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

    FDA Recall
    Terminated ·Exactech, Inc.·Product code OLO·July 11, 2017

    The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·September 12, 2012

    RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·October 7, 2014

    MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code OLO·February 27, 2017

    Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868

    FDA Recall
    Terminated ·Product code OLO·July 2, 2019

    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code OLO·April 11, 2014

    RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·October 7, 2014

    Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·July 16, 2015

    Robotic Arm Interactive Orthopedic System (RIO)

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·April 30, 2014

    RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·February 23, 2016

    Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·September 29, 2016

    Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

    FDA Recall
    Terminated ·Brainlab AG Olof-Palme-Strasse 9 Munich Germany·Product code OLO·October 27, 2016

    NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code OLO·February 27, 2020