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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 6.

Siemens Medical Solutions USA Inc. - Biograph mCT Flow 404R - Class 2 Recall
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determini...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT X3R - Class 2 Recall
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining var...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT Flow Edge4R - Class 2 Recall
Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determi...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT X4R - Class 2 Recall
Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining var...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT S(40)4R - Class 2 Recall
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT S(64)3R - Class 2 Recall
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT S(40)3R - Class 2 Recall
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCTX w/TrueV Upgrade - Class 2 Recall
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of de...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Bard Access Systems - SafeStep Huber Needle Set with YInjection Site - Class 2 Recall
SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - Eclipse Treatment Planning System version 13.MR2 - Class 2 Recall
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Bausch & Lomb, Inc. - AlgerbrushII - Class 2 Recall
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

ConforMIS, Inc. - The iTotal PS Knee Replacement System - Class 2 Recall
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Bard Access Systems - MiniLoc Safety Infusion Set Winged without YInjection Site - Class 2 Recall
MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

ICU Medical, Inc. - intravascular administration set - Class 2 Recall
133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Each set will be manufactured to a unique specifications using dimensions, components and configurations specified by the customer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

ICU Medical, Inc. - Tego Connector - Class 2 Recall
Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego¿ is a needle-free capping device which closes the end of the catheter. The Tego¿ will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

MEDLINE IND - Medline EZ Lubricating Jelly - Class 2 Recall
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Oncentra External Beam Treatment Planning Software - Class 2 Recall
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

HEALTH ROBOTICS S.R.L. - i.v. Station, i.v. Station ONCO - Class 2 Recall
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Bard Access Systems - StatLock CV Plus w/Pigtail - Class 2 Recall
StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock¿ PICC Plus and StatLock¿ CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Bard Access Systems - StatLock PICC Plus Crescent Foam - Class 2 Recall
StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock¿ PICC Plus and StatLock¿ CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - GE Healthcare Surgery OEC MiniView 6800 - Class 2 Recall
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

C.R. Bard, Inc. - SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device - Class 2 Recall
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - GE Healthcare Surgery OEC 9900 Elite - Class 2 Recall
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

Implant Direct Sybron Manufacturing, LLC - Replant Overdenture Abutment - Class 2 Recall
GoDirect Screw-Retaining Top Part Numbers: 4500-61 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE 2000/2000 XPi Intact Parathyroid Hormone (IPTH) - Class 2 Recall
SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma and serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - GE Healthcare Surgery OEC 9800 - Class 2 Recall
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

Advanced Sterilization Products - EVOTECH Endoscope Cleaner and Reprocessor System - Class 2 Recall
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

Amendia, Inc - CeresC Standalone Cervical Interbody, absent the tantalum market pin - Class 2 Recall
Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

Alcon Research, Ltd. - Alcon MONARCH III C Cartridge - Class 2 Recall
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Artis Zee/Zeego - Class 2 Recall
Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imagi...
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens Artis Q/Q.zen - Class 2 Recall
Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging...
Source: Medical Device Recalls - January 10, 2017 Category: Medical Equipment Source Type: alerts

Stryker Sustainability Solutions - Class 2 Recall
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation catheter and equipment out of immediate reach. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2017 Category: Medical Equipment Source Type: alerts

Stryker Sustainability Solutions - Class 2 Recall
Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables either interface an EP catheter with the appropriate external stimulation or recording equipment or, serve as an extension cable between an EP catheter and equipment out of immediate reach (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2017 Category: Medical Equipment Source Type: alerts

Medtronic Inc., Cardiac Rhythm and Heart Failure - AdaptivCRT (aCRT) - Class 2 Recall
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2017 Category: Medical Equipment Source Type: alerts

Straumann Manufacturing, Inc. - Class 2 Recall
Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

Straumann Manufacturing, Inc. - Class 2 Recall
Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - Oxford Fixed Lateral Partial Knee System - Class 2 Recall
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartment...
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

In2Bones, SAS - DRP SCREW - Class 2 Recall
SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

Natus Manufacturing Limited - Natus Warmette Blanket Cabinet and Warmette Dual Cabinet - Class 2 Recall
Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

In2Bones, SAS - DRP SCREW - Class 2 Recall
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

Trilliant Surgical Ltd. - Tiger Cannulated Screw System - Class 2 Recall
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

Voco GmbH - VOCO Futurabond M adhesive - Class 2 Recall
VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as well as without (self-etch). A1] Adhesive for direct restorations of all classes of cavities using light-curing composite /compomer / Ormocer materials with a methacrylate base. [A2] Adhesive for core build-ups made of light-curing composite materials. [A3] Adhesive for indirect restorations with light-curing luting composites. [B]...
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

In2Bones, SAS - DRP SCREW - Class 2 Recall
NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

Merit Medical Systems, Inc. - PreludeEASE - Class 2 Recall
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 6, 2017 Category: Medical Equipment Source Type: alerts

Aesculap Implant Systems LLC - Gomco Circumcision Clamps with separate ORing - Class 2 Recall
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 6, 2017 Category: Medical Equipment Source Type: alerts

Tepha Incorporated - GalaSHAPE 3D - Class 2 Recall
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 6, 2017 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - Modular Necks - Class 2 Recall
Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases ...
Source: Medical Device Recalls - January 5, 2017 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - Modular SMF(TM) - Class 2 Recall
Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases...
Source: Medical Device Recalls - January 5, 2017 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - Modular REDAPT(TM) Hip Systems - Class 2 Recall
Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a vari...
Source: Medical Device Recalls - January 5, 2017 Category: Medical Equipment Source Type: alerts

Interventional Spine Inc - G3 Opticage Expandable Interbody Fusion Device - Class 2 Recall
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with deg...
Source: Medical Device Recalls - January 4, 2017 Category: Medical Equipment Source Type: alerts