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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Notificaciones De Seguridad De Campo acerca de median occipital plaques oasyssystems of spinal fi...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    3832
  • Fecha
    2000-01-01
  • País del evento
    Italy
  • Fuente del evento
    MSHM
  • URL de la fuente del evento
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=3832
  • Notas / Alertas
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Italy.
  • Notas adicionales en la data
  • Acción
    Loading...
Retiro De Equipo (Recall) de PowerPro(R)Batteryxxx, PowerProMax(TM)Batteryxxx, Mpower™PROxxx
  • Tipo de evento
    Recall
  • ID del evento
    2009-0816
  • Fecha
    2009-08-20
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: M2
  • Causa
    Device failure / feature before use - material / component.
Notificaciones De Seguridad De Campo acerca de Universal Cable
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03082/09
  • Fecha
    2009-09-22
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/10/2009/03082-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de PowerPro, PowerProMax and Mpower Handpieces
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03076/09
  • Fecha
    2009-09-25
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2009/03076-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de powerpro, powerpromax and mpower cordless devices
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2636
  • Fecha
    2009-10-12
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-firmy-conmed-linvatec-dotycz%C4%85cy-wycofania-urz%C4%85dze%C5%84-akumulatorowych-powerpro-powerpromax-i
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
  • Notas adicionales en la data
  • Acción
    Communication from ConMed Linvatec concerning the withdrawal of the PowerPro, PowerProMax and Mpower cordless devices (12/10/2009)
Notificaciones De Seguridad De Campo acerca de Universal Cables
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03626/09
  • Fecha
    2009-10-26
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/10/2009/03626-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de surgical handpieces PowerPro®, PowerProMax™ and Mp...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03614/09
  • Fecha
    2009-10-26
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/12/2009/03614-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Synex II Modular Vertebral Body Replacement System
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    03552/09
  • Fecha
    2009-10-27
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2009/03552-09_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Ardis Inserter
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    LMST-2012121422
  • Fecha
    2012-12-11
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2012/ardis-inserter/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Ardis Inserter
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    LMST-2012121422
  • Fecha
    2012-12-21
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2012/ardis-inserter-21-december-2012/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de ARDIS Inserter worldwide
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    07561/12
  • Fecha
    2012-12-27
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/06/2012/07561-12_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de ardis inserter for ardis peek inserter for vertebr...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2073
  • Fecha
    2013-01-04
  • País del evento
    Italy
  • Fuente del evento
    MSHM
  • URL de la fuente del evento
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=2073
  • Notas / Alertas
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Italy.
  • Notas adicionales en la data
  • Acción
    recall of the device
Notificaciones De Seguridad De Campo acerca de Ardis® Interbody System
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    LMST-2012121422
  • Fecha
    2013-01-07
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/ardis-interbody-system/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de LPS Diaphyseal Sleeves
  • Tipo de evento
    Recall
  • ID del evento
    14113/1/13
  • Fecha
    2013-04-24
  • País del evento
    Lebanon
  • Fuente del evento
    RLMPH
  • URL de la fuente del evento
    https://www.moph.gov.lb/userfiles/medical_care/14113-1-13.pdf
  • Notas / Alertas
    Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Oasys Midline Plates
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2013052429
  • Fecha
    2013-05-24
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/oasys-midline-plates/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de median oasys systems of spinal fixation
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2358
  • Fecha
    2013-05-30
  • País del evento
    Italy
  • Fuente del evento
    MSHM
  • URL de la fuente del evento
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=2358
  • Notas / Alertas
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Italy.
  • Notas adicionales en la data
  • Acción
    product recall
Retiro De Equipo (Recall) de Oasys Midline Spine Surgery Plates
  • Tipo de evento
    Recall
  • Fecha
    2013-06-04
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/plaques-oasys-midline-pour-chirurgie-du-rachis-stryker-rappel-de-produit
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    ANSM has been informed of the implementation of a recall made by Stryker. The users concerned have received the attached mail. (04/06/2013) (70 KB)
Notificaciones De Seguridad De Campo acerca de the Oasys Midline Plates
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    02882/13
  • Fecha
    2013-06-21
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2013/02882-13_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
  • Notas adicionales en la data
Alerta De Seguridad para LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Comp...
  • Tipo de evento
    Safety alert
  • Fecha
    2013-07-19
  • Fecha de publicación del evento
    2013-07-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130719a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: depuy lps (limb preservation system) lower extremity dovetail intercalary component it has come to our attention that the medical device manufacturer, depuy orthopaedics, inc. has initiated a field safety corrective action concerning its lps (limb preservation system) lower extremity dovetail intercalary component. the affected part number is 1987-19-055. according to the manufacturer, the affected product has the potential for fracture of the female component when exposed to certain physiological loads. bench testing simulating loads under normal walking conditions demonstrated that patients over approximately 200 lbs. (90 kg) are at higher risk and that increasing weight may pose increasing risk. however, common activities such as stair ascent and descent and rising from chairs may exert forces higher than those under normal walking conditions. other factors such as the patient’s musculature, activity level, and overall health should also be considered. the possible clinical implications related to this issue, which could only occur if the product should fracture, include: poor mechanics and loss of function pain dislocation: the separation of the male component from the female component adverse tissue reaction if the broken piece of the female component were to completely break free and cause irritation to the surrounding tissue. damage to bone in areas that are important for revision surgery. surgeon may be unable to conduct revision surgery due to lack of sufficient bone stock, potentially resulting in amputation if no other therapeutic options remain available. the clinical implications above may lead to revision surgery. depuy provides the following advice to the affected customers: customers are advised to stop further distribution or use of the affected products immediately for use in primary surgery. depuy is not recommending prophylactic revision in the absence of symptoms. however, surgeons are encouraged to communicate with patients who received these implants as deemed appropriate (considering weight and activity level). depuy recommends that surgeons review each patient’s case to determine the best treatment options, considering the patient’s weight, activity level and/or any other potential contributing factors. if a patient presents with a fractured lps lower extremity dovetail intercalary component with well‐fixed proximal and distal stems and the surgeon determines that the lps lower extremity dovetail intercalary component is the best treatment option, the company will make the lps lower extremity dovetail intercalary component available. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 july 2013.
Retiro De Equipo (Recall) de Oasys midline occiput plates
  • Tipo de evento
    Recall
  • ID del evento
    2013-1350
  • Fecha
    2013-07-30
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: NCAR
  • Causa
    Device failure / feature after commissioning - mechanical failure.
Notificaciones De Seguridad De Campo acerca de the Oasys Midline Plates
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    02882/13
  • Fecha
    2013-08-29
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2013/02882-13a_Kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
  • Notas adicionales en la data
Retiro De Equipo O Alerta De Seguridad para LPS Lower Extremity Dovetail Intercalary Component
  • Tipo de evento
    Recall / Safety Alert
  • ID del evento
    31-127(A)-MD/2006-DC (Re-Reg. 02)
  • Fecha
    2013-12-11
  • País del evento
    India
  • Fuente del evento
    CDSCO
  • URL de la fuente del evento
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notas / Alertas
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
  • Notas adicionales en la data
  • Causa
    Lps is a limb preservation system. one of its component of the i.E lower extremity dovetail intercalary component has the potential for the fracture of the female component when exposed to certain physiological loads. this recall is only applied or this component and not the whole knee system.
  • Acción
    - Safety Communication to Inform physicians and patients about the risk of catheter entrapment associated with the use of Onyx. - Specific Changes in the Information of Use to include addltional safety information
Notificaciones De Seguridad De Campo acerca de offset impactor for acetabular cups standard instr...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2843
  • Fecha
    2014-02-13
  • País del evento
    Italy
  • Fuente del evento
    MSHM
  • URL de la fuente del evento
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=2843
  • Notas / Alertas
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Italy.
  • Notas adicionales en la data
  • Acción
    Loading...
Notificaciones De Seguridad De Campo acerca de Standard Offset Cup Impactor
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    V20017
  • Fecha
    2014-02-17
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/docs/default-source/field-safety-notices/jan-may-2014-fsn-summary-sheets/fsnsummary_feb2014_qmsversion_finalupdated_220714.pdf?sfvrsn=2
  • Notas / Alertas
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland.
  • Notas adicionales en la data
    Advice regarding changes/updates made to instructions for use. 3rd Party Publications
Alerta De Seguridad para Standard Offset Cup Impactor
  • Tipo de evento
    Safety alert
  • Fecha
    2014-03-13
  • Fecha de publicación del evento
    2014-03-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140313a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: greatbatch medical standard offset cup impactor the united states food and drug administration (fda) has issued a medical device safety alert concerning standard offset cup impactor manufactured by greatbatch medical. the affected device was manufactured from january 2004 through january 2013 and distributed from january 2004 through december 2013. the manufacturer has identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current instructions for use provided with the device. the manufacturer has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue. greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels (aami st79 standard). customers who have the affected product should immediately begin utilizing the new sterilization instructions. for details, please refer to the following fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1119-2014&w=03122014&lang=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm388928.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm389005.Htm http://www.Fda.Gov/safety/recalls/ucm388883.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 march 2014.
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