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    PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MRW·March 15, 2011

    Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MRW·March 15, 2011

    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MAX·November 22, 2016

    Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- a sterile, medical device kit consisting of the components: PERPOS Access Needle, PERPOS K-Wires, PERPOS 2-in-1 Drill, PERPOS Tap, PERPOS Device Driver, 4.5mm BONE-LOK PLS Implant, and PERPOS Pull Pin Remover. The kit is used by medical professions to stablize the spine as an aid to fusion through immobilization of the facet joints.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HTW·February 22, 2008

    PERPOS PLS System, Single Use; CATALOG #'s 9045-01 & 9045-02. Interventional Spine, Inc. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXX·February 3, 2011

    PERPOS PLS SYSTEM, CATALOG NO. 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXI·March 23, 2011

    PERPOS PLS SYSTEM, CATALOG NO. 9045-01 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints. A Surgical Technique brochure is provided in Appendix A and other labeling, including instructions for use, is provided in Appendix B.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXI·March 23, 2011

    PERPOS Driver; Catalog # 6112 Interventional Spine, Inc. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXX·February 3, 2011

    PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02) or as a stand-alone tool.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HTW·February 22, 2008

    Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. Interventional Spine, Inc. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Sold in Europe.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXX·February 3, 2011

    Merit Medical Systems, Inc. Monarch Inflation Syringe CATALOG NUMBER IN2230 for inflation and deflation of interventional devices

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DXT·September 29, 2009

    Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·October 30, 2015

    Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: MONARCH CATALOG NUMBER IN2130 for inflation and deflation of interventional devices

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DXT·September 29, 2009

    Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60

    FDA Recall
    Terminated ·Power Medical Interventions, Inc·Product code GDW·May 12, 2007

    HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

    FDA Recall
    Terminated ·Nitinol Devices and Components, Inc.·Product code DQX·May 28, 2014

    Celsite Access Port Model ST305P. The Celsite Access Port model ST305P is a member of the Celsite product line of implantable port and catheter systems.

    FDA Recall
    Terminated ·B. Braun Interventional Systems·Product code LJT·June 22, 2009

    Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code MQB·October 1, 2007

    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

    FDA Recall
    Terminated ·Nitinol Devices and Components, Inc.·Product code DQX·May 28, 2014

    HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

    FDA Recall
    Terminated ·Nitinol Devices and Components, Inc.·Product code DQX·May 28, 2014

    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

    FDA Recall
    Terminated ·Nitinol Devices and Components, Inc.·Product code DQX·May 28, 2014