Intrinsic Therapeutics, Inc. - Barricaid Annular Closure Device (ACD) - Class 2 Recall
Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation, and confirmed by history, physical examination and imaging studies which demonstrate neural compression using MRI to treat a large annular defect (between 4-6 mm tall and between 6-10 mm wide) following a primary discectomy procedure (excision of herniated intervertebral disc) at a single level between L4 and S1. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 14, 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
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 - 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 - Artisan TM - Class 2 Recall
ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) Manual - Product Usage: The surgical paddle leads function as a component of Boston Scientific s spinal cord stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in a inhibition of pain sensation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts
Boston Scientific Neuromodulation Corporation - LinearTM 34 - Class 2 Recall
LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. 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 Labels left and right (non-sterile) (1) ...
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts
ABSORBINE BACK THERAPEUTIC PAIN RELIEF (Menthol) Patch [Teh Seng Pharmaceutical Mfg. Co., Ltd.]
Updated Date: Wed, 16 Oct 2019 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 16, 2019 Category: Drugs & Pharmacology Source Type: alerts
LAV PREMIUM HEMP FOR NECK AND BACK PAIN ARTHRITIS RELIEF (Menthol) Cream [LAV CBD Inc]
Updated Date: Tue, 08 Oct 2019 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 8, 2019 Category: Drugs & Pharmacology Source Type: alerts
NAPROXEN BACK AND MUSCLE PAIN (Naproxen Sodium) Tablet, Film Coated [L.N.K. International, Inc.]
Updated Date: Thu, 03 Oct 2019 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 3, 2019 Category: Drugs & Pharmacology Source Type: alerts
AVON HEXASHIELD PAIN RELIEF FOR MUSCLE, BACK AND JOINT CREAM (Camphor, Menthol, Methyl Salicylate) Cream [Tai Guk Pharm. Co., Ltd.]
Updated Date: Aug 5, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 5, 2019 Category: Drugs & Pharmacology Source Type: alerts
TOPCARE BACK AND MUSCLE PAIN (Naproxen Sodium) Tablet, Film Coated [Topco Associates LLC]
Updated Date: Jul 10, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 10, 2019 Category: Drugs & Pharmacology Source Type: alerts
BACK AND MUSCLE PAIN (Naproxen Sodium) Tablet, Film Coated [Rite Aid Corporation]
Updated Date: Jun 12, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 12, 2019 Category: Drugs & Pharmacology Source Type: alerts
BACK AND MUSCLE PAIN (Naproxen) Tablet, Coated [WALGREENS]
Updated Date: Jun 3, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 3, 2019 Category: Drugs & Pharmacology Source Type: alerts
PF Consumer Healthcare 1 LLC - ThermaCare HEATWRAPS - Class 2 Recall
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2019 Category: Medical Devices Source Type: alerts
PF Consumer Healthcare 1 LLC - ThermaCare HEATWRAPS - Class 2 Recall
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to pro...
Source: Medical Device Recalls - May 29, 2019 Category: Medical Devices Source Type: alerts
