Oakworks Inc - Oakworks Imaging Tables - Class 2 Recall
OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical...
Source: Medical Device Recalls - May 24, 2019 Category: Medical Devices Source Type: alerts
ABSORBINE BACK THERAPEUTIC PAIN RELIEF (Menthol) Patch [Teh Seng Pharmaceutical Mfg. Co., Ltd.]
Updated Date: Apr 25, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 25, 2019 Category: Drugs & Pharmacology Source Type: alerts
MUSCLESHOK BACK PAIN (Histamine Dihydrochloride) Gel [Wagner Solutions, LLC]
Updated Date: Mar 12, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 12, 2019 Category: Drugs & Pharmacology Source Type: alerts
NAPROXEN BACK AND MUSCLE PAIN (Naproxen Sodium) Tablet, Film Coated [L.N.K. International, Inc.]
Updated Date: Feb 1, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 1, 2019 Category: Drugs & Pharmacology Source Type: alerts
BACK PAIN AND SCIATICA (Aconitum Napellus, Arnica Montana, Belladonna, Cimicifuga Racemosa, Euphorbium Officinarum, Gelsemium Sempervirens, Gnaphalium Polycephalum, Hypericum Perforatum, Magnesia Phosphorica, Phytolacca Decandra, Ranunculus Bulbosus, Rhus Tox) Spray [Liddell Laboratories, Inc.]
Updated Date: Feb 1, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 1, 2019 Category: Drugs & Pharmacology Source Type: alerts
Pfizer Inc. - Thermacare HeatWraps Menstrual - Class 2 Recall
Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 6, 2018 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, scolios...
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) 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 - 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 fa...
Source: Medical Device Recalls - July 13, 2018 Category: Medical Devices Source Type: alerts
Neuropro Spinal Jaxx - Spinal Jaxx Interbody Fusion Device - Class 2 Recall
Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Ja...
Source: Medical Device Recalls - April 11, 2018 Category: Medical Devices Source Type: alerts
PAIN RELIEF BACK AND BODY EXTRA STRENGTH (Aspirin, Caffeine) Tablet, Film Coated [Rite Aid Corporation]
Updated Date: Mar 6, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 6, 2018 Category: Drugs & Pharmacology Source Type: alerts
Oakworks Inc - OAKWORKS Medical Imaging Tables - Class 2 Recall
"OAKWORKS¿ Medical CFPM 300 Imaging Table "OAKWORKS¿ Medical CFPM 301 Imaging Table "OAKWORKS¿ Medical CFPM 400 Imaging Table "OAKWORKS¿ Medical CFPM 401 Imaging Table "OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table "OAKWORKS¿ Medical CFUR 301 Urology Table "OAKWORKS¿ Medical CFUR 401 Urology Table "OAKWORKS¿ Medical CFLU 401 Lithotripsy/Urology Table Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeu...
Source: Medical Device Recalls - February 24, 2018 Category: Medical Devices Source Type: alerts
ALEVE BACK AND MUSCLE PAIN (Naproxen Sodium) Tablet [Bayer HealthCare LLC.]
Updated Date: Jan 26, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 26, 2018 Category: Drugs & Pharmacology Source Type: alerts
SPINEART SA - TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW - Class 2 Recall
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and...
Source: Medical Device Recalls - January 14, 2018 Category: Medical Devices Source Type: alerts
SPINEART SA - TRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREW - Class 2 Recall
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and...
Source: Medical Device Recalls - January 14, 2018 Category: Medical Devices Source Type: alerts
