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    Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·April 3, 2013

    Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo.

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

    Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)

    FDA Recall
    Terminated ·Advanced Back Technologies, Inc.·Product code ITH·May 13, 2015

    Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)

    FDA Recall
    Terminated ·Advanced Back Technologies, Inc.·Product code ITH·May 13, 2015

    Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)

    FDA Enforcement
    Class II ·Terminated·Advanced Back Technologies, Inc.·June 17, 2015

    Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)

    FDA Enforcement
    Class II ·Terminated·Advanced Back Technologies, Inc.·June 17, 2015

    RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code KWP·March 18, 2016

    Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIT·August 28, 2014

    AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; manufactured by Hudson Respiratory Care, Inc., Temecula, CA 92589-9020 USA; catalog #037-00

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·December 1, 2005

    Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.

    FDA Recall
    Terminated ·PIONEER SURGICAL TECHNOLOGY, INC.·Product code JDQ·June 11, 2014

    LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a small incision.

    FDA Recall
    Terminated ·Stryker Spine·Product code GAD·April 23, 2012

    Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the inner package have been sterilized by ethylene oxide gas. 20 mL reservoir. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic SynchroMed II Programmable Pump, model 8637-40. The contents of the inner package have been sterilized by ethylene oxide gas. 40 mL reservoir. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components; product number RLA-142-3

    FDA Recall
    Terminated ·Teleflex Medical·Product code FCM·July 11, 2005

    Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, screened side catheter access port and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve and screened side catheter access port. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve and screened side catheter access port. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

    Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve, screened side catheter access port and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008