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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Device Recall VNS Therapy AspireHC Pulse Generator
  • Modelo / Serial
    Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Distributed to PA.
  • Descripción del producto
    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.
  • Manufacturer
    Cyberonics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VNS Therapy AspireHC Pulse Generator
Device Recall Trilogy Bone Screws
  • Modelo / Serial
    Item Number Lot Number 00-6250-065-35 62748089 00-6250-065-35 62754329 00-6250-065-35 62793494 00-6250-065-35 62793495 00-6250-065-35 62793501 00-6250-065-35 62793502 00-6250-065-35 62793503 00-6250-065-35 62813612 00-6250-065-35 62813613 00-6250-065-25 62784617 00-6250-065-25 62784618 2 00-6250-065-25 62784619 00-6250-065-25 62784621 00-6250-065-25 62784622 00-6250-065-25 62818701 00-6250-065-25 62818702 00-6250-065-25 62818703 00-6250-065-25 62818707 00-6250-065-25 62818709 00-6250-065-25 62818710 00-6250-065-25 62825611 00-6250-065-25 62836984
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Trilogy Bone Screws
Device Recall Conformis iTotal CR G2 Knee Replacement System
  • Modelo / Serial
    Serial Number: 0340552
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed to IN.
  • Descripción del producto
    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.
  • Manufacturer
    ConforMIS, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Conformis iTotal CR G2 Knee Replacement System
Device Recall The HemiCAP Contoured Articular Prosthetic
  • Modelo / Serial
    Catalog Number: 6105-0028, Part Number 1105-0028
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Arthrosurface, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
Device Recall The HemiCAP Contoured Articular Prosthetic
  • Modelo / Serial
    Catalog Number: 6125-0035, Part Number: 1125-0035
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
  • Manufacturer
    Arthrosurface, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
Device Recall The HemiCAP Contoured Articular Prosthetic
  • Modelo / Serial
    Catalog Number: 8135-0032, Part Number: 3135-0032
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
  • Descripción del producto
    Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
  • Manufacturer
    Arthrosurface, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
Device Recall The HemiCAP Contoured Articular Prosthetic
  • Modelo / Serial
    Catalog Number: 8135-1875 Part Number: 3135-1875
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
  • Descripción del producto
    Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
  • Manufacturer
    Arthrosurface, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
Device Recall The HemiCAP Contoured Articular Prosthetic
  • Modelo / Serial
    Catalog Number: 8156-0032, Part Number: 156-0032
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA nationwide. Internationally distributed to Europe, Canada, and Australia. Only products in US affected by this recall.
  • Descripción del producto
    Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
  • Manufacturer
    Arthrosurface, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall The HemiCAP Contoured Articular Prosthetic
Device Recall Osteobond Copolymer Bone Cement
  • Modelo / Serial
    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
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed to MI, KS, and CA.
  • Descripción del producto
    Osteobond Bone Cement || Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
  • Manufacturer
    Zimmer, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Osteobond Copolymer Bone Cement
Device Recall Persona Cemented Tibial Broach Inserter/Extractor
  • Modelo / Serial
    Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Zimmer, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Persona Cemented Tibial Broach Inserter/Extractor
Device Recall WECK Hemoclip
  • Modelo / Serial
    Product Code: 523300, Lot number: 01B1400034
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Teleflex Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall WECK Hemoclip
Device Recall Lotus Valve System
  • Modelo / Serial
    Serial numbers: 14113043, 14118011, 14118012, 14119047, 14119048, 14119049, 14119050, 14119051, 14120027, 14120028, 14120029, 14120030, 14120031, 14121035, 14121036, 14121037, 14121038, 14121039, 14121040, 14121041, 14125040, 14125041, 14125042, 14125043, 14125044, 14125045, 14125046, 14125047, 14125048, 14125049, 14127073, 14127077, 14127078, 14127079, 14127080, 14127081, 14127082, 14127083, 14127084, 14127085, 14127086, 14141044, 14141045, 14141046, 14141047, 14141048, 14141049, 14141050, 14141051, 14141052, 14141053, 14148034, 14148035, 14148036, 14148037, 14148039, 14153054, 14153055, 14153057, 14153058, 14153059, 14153075, 14153076, 14153077, 14153078, 14153079, 14157003, 14157015, 14157016, 14157017, 14157019, 14157020, 14157021, 14157022, 14157023, 14178024, 14178025, 14178026, 14178027, 14178028. Nov. 15, 2014 to Jan. 24, 2015.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Lotus Valve System
Device Recall Lotus Valve System
  • Modelo / Serial
    Serial numbers: 14126051, 14126052, 14126053, 14127058, 14128047, 14128048, 14128049, 14128050, 14129004, 14129005, 14129006, 14129007, 14129008, 14133006, 14133007, 14133008, 14133009, 14133010, 14134042, 14134043, 14134044, 14134045, 14134047, 14134049, 14134050, 14134054, 14148005, 14148006, 14148007, 14148008, 14148009, 14148010, 14148011, 14148012, 14148013, 14148014, 14148015, 14148019, 14148020, 14148021, 14148022, 14148023, 14148024, 14148026, 14148027, 14156025, 14156026, 14157007, 14157008, 14157009, 14157010, 14157011, 14157012, 14157013, 14160009, 14160011, 14160012, 14160015, 14161036, 14161037, 14161038, 14161040, 14162050, 14162051, 14162053, 14162054, 14163052, 14163053, 14163054, 14163055, 14165004, 14165005, 14165006, 14165007, 14165008, 14167012, 14167013, 14167015, 14167016, 14167017, 14167018, 14167019, 14167020, 14167021, 14170001, 14170002, 14170003, 14170004, 14170005, 14170031, 14170032, 14170034, 14170035, 14170036, 14170037, 14170038, 14170039, 14170040, 14171031, 14171032, 14171033, 14171036, 14171037, 14171038, 14171039, 14171040, 14172017, 14172018, 14172019, 14172020, 14172021, 14172022, 14172023, 14172024, 14176021, 14176022, 14176023, 14176024, 14176025, 14176029, 14176030, 14176031, 14176032, 14176033, 14178036, 14178038, 14178039, 14178040, 14178041, 14178042, 14178043, 14178045, 14179048, 14179050, 14179051, 14179052, 14179053, 14179054, 14179055, 14179057, 14182027, 14182029, 14182031, 14183011, 14183013, 14183014, 14183015, 14184003, 14184004, 14184005, 14184006, 14184007, 14184008, 14184009, 14184010, 14184011, 14188009, 14188010, 14188012, 14188013, 14188014, 14188015, 14188016, 14188017, 14188018, 14191021, 14191022, 14191023, 14191024, 14191030, 14193002, 14193003, 14193007, 14193011, 14193012, 14193013, 14193014, 14193022, 14197042, 14197047, 14197048, 14197049. Expiry Datres Nov. 15, 2014 to Jan. 24, 2015.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Lotus Valve System
Device Recall Lotus Valve System
  • Modelo / Serial
    Serial numbers: 14076030, 14076031, 14079012, 14079013, 14149023, 14149031, 14149038, 14149040, 14150028, 14150029, 14153080, 14153081, 14153082, 14154040, 14157024, 14157025, 14157026, 14157027, 14157029, 14157030, 14157031, 14157032, 14157033, 14165041, 14165042, 14165043, 14165044, 14175039, 14175040, 14175041, 14175042, 14175043, 14175044, 14175045, 14175047, 14178019, 14178020, 14198066, 14198067, 14198068, 14198069. Expiry Datres Nov. 15, 2014 to Jan. 24, 2015.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Lotus Valve System
Device Recall Sirius Polish Cemented Stem 34B
  • Modelo / Serial
    Sirius Polish Cemented Stem 348 Catalog Number: 51-199333 Lot Number Identification: 024320
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Foreign Distribution in China and Australia only.
  • Descripción del producto
    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.
  • Manufacturer
    Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Sirius Polish Cemented Stem 34B
Device Recall Sirius Polish Cemented Stem 34B
  • Modelo / Serial
    Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Foreign Distribution in China and Australia only.
  • Descripción del producto
    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.
  • Manufacturer
    Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Sirius Polish Cemented Stem 34B
Device Recall Arrow
  • Modelo / Serial
    Lot numbers: RF2095946, RF2056557, RF2058764, RF2060829,  RF2084897, RF2084162, RF2071325,RF2060831, RF2083836, RF2096027, RF2107409, RF2108329, RF2119933, RF2060836, RF2060899, RF2083837,  RF2084898, RF2107410, RF2108324, RF2071317, RF2121827, RF2058355,  RF2060414, RF2108326, RF2060811, RF2110441, RF2069798, RF2121821,  RF2069964, RF2122497, RF2110442, RF2058357, RF2119935, RF2108330,  RF2121820, RF2057719, RF2056545, RF2111259, RF2096348.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US and Canada.
  • Descripción del producto
    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.
  • Manufacturer
    Arrow International Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Arrow
Device Recall Protg Rx Tapered Carotid Stent System
  • Modelo / Serial
    Lot # 9922452
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Ev3, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Protg Rx Tapered Carotid Stent System
Device Recall Protg Rx Tapered Carotid Stent System
  • Modelo / Serial
    Lot # 9922795
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Ev3, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Protg Rx Tapered Carotid Stent System
Device Recall SolitaireC Cervical Spacer System
  • Modelo / Serial
    Part number 14-531593 Part number 14-531594  Catalog number Lot Number 14-531593 N23597  14-531594 N23599
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    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.
  • Manufacturer
    Ebi, Llc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SolitaireC Cervical Spacer System
Device Recall BIOLOX delta TS Ceramic Femoral Head Articul/eze 12/14 36mm 12
  • Modelo / Serial
    Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BIOLOX delta TS Ceramic Femoral Head Articul/eze 12/14 36mm 12
Device Recall TiBond
  • Modelo / Serial
    All revisions
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    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.
  • Manufacturer
    Spinal Elements, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TiBond
Device Recall Timberline Anchored Lateral Retractable Drill
  • Modelo / Serial
    Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Biomet Spine, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Timberline Anchored Lateral Retractable Drill
Device Recall Timberline Anchored Lateral Variable Retractable Sleeve
  • Modelo / Serial
    Model 8630-0204 Lots TU00052, TU00052A, and TU00117
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Manufacturer
    Biomet Spine, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Timberline Anchored Lateral Variable Retractable Sleeve
Device Recall Merlinhome RF Remote Monitoring Transmitter, Model EX1150, with software versions ...
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).
  • Descripción del producto
    Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. || Usage:RF Remote Transmitter
  • Manufacturer
    St Jude Medical Cardiac Rhythm Management Division
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merlinhome RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.