Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts

Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts

Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts

Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts

Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-RCV-A0 US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts

Stimwave Technologies Inc - StimQ Peripheral Nerve Stimulator System - Class 2 Recall
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-RCV-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 3, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific Neuromodulation Corporation - LinearTM 34 - Class 2 Recall
The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labelsleft and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific Neuromodulation Corporation - None - Class 2 Recall
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact extension kits are part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. They are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts

Boston Scientific Neuromodulation Corporation - PrecisionTM - Class 2 Recall
Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only 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, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts

Molnlycke Health Care, Inc - EZ Derm Porcine Xenograft - Class 2 Recall
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perfo...
Source: Medical Device Recalls - May 1, 2019 Category: Medical Devices Source Type: alerts

Back 2 Basics Direct LLC - Dymaxeon Spine System - Class 2 Recall
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine 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/iliac spine (T1 S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosi...
Source: Medical Device Recalls - August 22, 2018 Category: Medical Devices Source Type: alerts

Medtronic Neuromodulation - Vectris Trial Screening Lead Kit for Spinal Cord Stimulation - Class 2 Recall
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A 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 fai...
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices Source Type: alerts

Medtronic Neuromodulation - Vectris Trial Screening Lead Kit for Spinal Cord Stimulation - Class 2 Recall
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A 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: Faile...
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices Source Type: alerts

Medtronic Neuromodulation - SynchroMed II Implantable Drug Infusion System - Class 2 Recall
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: 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 solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free...
Source: Medical Device Recalls - December 20, 2016 Category: Medical Equipment Source Type: alerts

Medtronic Neuromodulation - RestoreSensor and RestoreSensor SureScan - Class 2 Recall
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 8, 2016 Category: Medical Equipment Source Type: alerts

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 stenosis...
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. Res...
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 - Unsucce...
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 solution in ...
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 fluids: Ch...
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 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 di...
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 X80MM Tl Product Code: 1867-15-880 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 10X100MM Tl Product Code: 1867-15-199 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 dis...
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 X70MM Tl Product Code: 1867-15-970 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 10 X 70MM Tl Product Code: 1867-15-170 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 d...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts

DePuy Spine, Inc. - Class 2 Recall
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 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 d...
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 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 di...
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 di...
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 dis...
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts