Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. || Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Worldwide Distribution - USA (nationwide) and Internationally to Canada Australia Brazil Chile China Colombia Japan Malaysia Singapore South Korea Taiwan Albania Austria Belgium Bulgaria Canary Islands Czech Republic Denmark Egypt Finland France Germany Greece Hungary Ireland Italy Netherlands Norway Poland Portugal Russia Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey and United Kingdom.
Descripción del producto
Bone Screw, self-tapping || The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Conformis iTotal CR G2 Knee Replacement System || Catalog/Model #: M57250600010 || Intended for use as a total knee replacement in patients with knee joint pain and disability.
Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
Descripción del producto
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
PMA #N17755, decision date 5/17/1976, reclassified 10/14/1999. Class II device; D033511, Item No. 00-1101-012-00; lot 62849791, 14D0809, Manufactured between 9/11/2014-10/6/2014; EXP date: 4/30/2017
Distributed in the states of MN; NJ; NC; PA; AL; MI; OR; FL; OH; CO; IL and CA, and the countries of Australia, India, UAE, Germany, and Italy.
Descripción del producto
Persona Cemented Tibial Broach Inserter/Extractor. || The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
US (nationwide) including the states of AL, CA, FL, DE, IA, IL, IN, KY, MA, MN, NC, NE, NJ, NY, NV, OH, OK, PA, TX, VA, VT, and WA.
Descripción del producto
WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. || Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
Descripción del producto
Lotus TAVR 23mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV230, Catalog Number LTV23; || Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
Descripción del producto
Lotus TAVR 25mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV250, Catalog Number LTV25; || Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
Descripción del producto
Lotus TAVR 27mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV270, Catalog Number LTV27; || Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
Device Brand Name: Sirius Polish Cemented Stem 34B || Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented || Device Common Name: Sirius Femoral Stem || The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.
Sirius Polish Cemented Stem 38C || Catalog Number: 51-199335 || Lot Number Identification: 141680, 180920 || The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. || The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis.
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Descripción del producto
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Descripción del producto
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Solitaire-C Cervical Spacer System || a) 14-531593 Drill/Awl Sleeve || b) 14-531594 Spring-Loaded Drill/Awl Sleeve || Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
Descripción del producto
Ceramic Femoral Head. || Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 || This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Distributed in PR and the states of NY, AZ, TN, TX, and CA.
Descripción del producto
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. || Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
Descripción del producto
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 || Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.