Neurotherm, Inc. - Class 2 Recall
Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 25, 2016 Category: Medical Equipment Source Type: alerts
CHRONIC PAIN/FEVER RELIEF (Aspirin Delayed Release Tablets, 81 Mg) Tablet [We Care Distributor Inc.]
Updated Date: Mar 1, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Medtronic Neuromodulation - Specify neurostimulation leads - Class 2 Recall
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2016 Category: Medical Equipment Source Type: alerts
Genesys Orthopedics Systems, LLC - The TiLock Pedicle Screw System - Class 2 Recall
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 stenos...
Source: Medical Device Recalls - September 23, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - RestoreUltra and RestoreSensor - Class 2 Recall
Medtronic, Restore¿ (37711), RestoreADVANCED¿ (37713), RestoreADVANCED¿ SureScan¿ MRI (97713), RestoreSENSOR¿ (37714), RestoreSENSOR¿ SureScan¿ MRI (97714),PrimeAdvanced¿ SureScan MRI, (97702),RestoreULTRA¿ (37712),RestoreULTRA¿ SureScan¿ MRI (97712) Itrel¿4 (37703),Itrel¿4 (37704),RestorePrime¿ (37701),PrimeAdvanced¿ (37702), Spinal cord Stimulation for chronic pain. All Restore, PrimeAdvanced¿ and Itrel 4 devices are used for Spinal Cord Stimulation. All Activa devices are used for Deep Brain Stimulation. Restore¿ (Model 37711),...
Source: Medical Device Recalls - April 30, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - RestoreUltra and RestoreSensor - Class 2 Recall
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsu...
Source: Medical Device Recalls - November 1, 2013 Category: Medical Equipment Source Type: alerts
St. Jude Medical - Eon Mini - Class 2 Recall
Eon Mini - 3788 (IPG), Eon Mini 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 the following: failed back, surgery syndrome, intractable low back and leg pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 1, 2013 Category: Medical Equipment Source Type: alerts
St. Jude Medical - Eon Mini Charging System - Class 2 Recall
Eon Mini - 3721 (Charger). Product Usage: Eon Mini 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 the following: failed back surgery syndrome, intractable low back and leg pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2013 Category: Medical Equipment Source Type: alerts
St. Jude Medical - Eon Charging System - Class 2 Recall
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon 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 the following: failed back surgery syndrome, intractable low back and leg pain. Eon Mini: Eon Mini 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 the following: failed back surgery syndrome, intractable low back and leg pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 17, 2013 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - SynchroMed II Implantable Infusion Pump - Class 1 Recall
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile sol...
Source: Medical Device Recalls - June 26, 2013 Category: Medical Equipment Source Type: alerts
Medtronic Neuromodulation - SynchroMed II Implantable Infusion Pump - Class 1 Recall
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or...
Source: Medical Device Recalls - June 26, 2013 Category: Medical Equipment Source Type: alerts
DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts
DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc ...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts
DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts
DePuy Spine, Inc. - DePuy Synthes - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Product Usage: The EXPEDIUM¿ and VIPER¿ Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM¿ and VIPER¿ Spine System are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts
