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    Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System

    FDA Recall
    Terminated ·Advanced Bionics Corporation·Product code LGW·November 11, 2004

    Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Power Supply (1) Adhesive Kit ADVANCED BIONICS CORP 12740 San Fernando Rd. Sylmar, CA 91342 USA. The Precision Spinal Cord Stimulator System (Precision System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable 16-output, multi-channel stimulator (IPG - Implantable Pulse Generator) with a rechargeable battery power source. The IPG, commonly implanted in the abdomen or buttock area (less frequently in the subclavicular area), can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals. An externally used Charger is utilized to transcutaneously recharge the IPG (Implantable Pulse Generator) battery. Currently, Boston Scientific distributes Charger 2.0 (Model Number SC-5312). For improved heat management, Charger 2.0 is equipped with thermistor (temperature sensing component), designed to activate/deactivate charging at a set temperature.

    FDA Recall
    Terminated ·Advanced Bionics Corp·Product code LGW·September 22, 2008

    Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·March 20, 2013

    Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 18, 2010

    Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 18, 2010

    Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LHX·January 18, 2010

    Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 18, 2010

    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).

    FDA Enforcement
    Class II ·Terminated·Genesys Orthopedics Systems, LLC·October 1, 2014

    Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 19, 2014

    Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.

    FDA Recall
    Terminated ·Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342·Product code LGW·September 21, 2006

    Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code MNH·January 11, 2013

    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).

    FDA Recall
    Terminated ·Genesys Orthopedics Systems, LLC·Product code NKB·April 2, 2014

    Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code HRS·January 27, 2014

    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 Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 10, 2016

    GIZA Vertebral Body Replacement

    FDA Recall
    Terminated ·Eden Spine Europe SA rue du·Product code MQP·March 17, 2017

    OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable l6-output, multi-channel stimulator (lPO - Implantable Pulse Generator) with a rechargeable battery power source. The lPG, commonly implanted in the abdomen or buttock area, can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals.

    FDA Recall
    Terminated ·Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342·Product code LGW·April 22, 2008

    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