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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Retiro De Equipo (Recall) de Various Polyethylene Implants
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00268-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-02-24
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00268-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Zimmer biomet is conducting a lot specific medical device recall for various polyethylene implants. the affected products are being removed due to the potential presence of elevated endotoxin levels that exceed the specification limit. the issue was discovered during routine bacterial endotoxin testing (bet). to date, no complaints related to this issue have been received.
  • Acción
    The relevant Zimmer Biomet sales representative will remove the affected product from each affected facility. There are no specific patient monitoring instructions that are recommended beyond the existing surgical follow-up protocol.
Retiro De Equipo (Recall) de Profemur Neck varus/valgus cocr 8 degree, part number PHAC
  • Tipo de evento
    Recall
  • Fecha
    2015-10-07
  • País del evento
    Lebanon
  • Fuente del evento
    RLMPH
  • URL de la fuente del evento
    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202015/7-10-2015/ProfemurNeckvarusvalguscocr8degreepartnumberPHAC.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
Retiro De Equipo (Recall) de Comprehensive Reverse Shoulder Tray
  • Tipo de evento
    Recall
  • Fecha
    2017-01-24
  • País del evento
    Lebanon
  • Fuente del evento
    RLMPH
  • URL de la fuente del evento
    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202017/24-1-2017/ComprehensiveReverseShoulderTray.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
Retiro De Equipo (Recall) de Comprehensive Reserve shoulder system humeral
  • Tipo de evento
    Recall
  • Fecha
    2017-02-20
  • País del evento
    Lebanon
  • Fuente del evento
    RLMPH
  • URL de la fuente del evento
    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202017/20-2-2017/ComprehensiveReserveshouldersystemhumeral.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
Retiro De Equipo (Recall) de EBI OsteoGen Implantable Bone Growth Stimulator
  • Tipo de evento
    Recall
  • Fecha
    2018-03-26
  • País del evento
    Lebanon
  • Fuente del evento
    RLMPH
  • URL de la fuente del evento
    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202018/26-3-2018/EBIOsteoGenImplantableBoneGrowthStimulator.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
Retiro De Equipo (Recall) de Biomet RINGLOC Instrumentation Impactor Plate
  • Tipo de evento
    Recall
  • ID del evento
    45987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0701-2008
  • Fecha de inicio del evento
    2007-10-18
  • Fecha de publicación del evento
    2008-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66622
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Acetabular Inserter Instrument - Product Code LXH
  • Causa
    The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
  • Acción
    Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.
Retiro De Equipo (Recall) de Biomet RINGLOC Instrumentation Impactor Plate
  • Tipo de evento
    Recall
  • ID del evento
    45987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0702-2008
  • Fecha de inicio del evento
    2007-10-18
  • Fecha de publicación del evento
    2008-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66623
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Acetabular Inserter Instrument - Product Code LXH
  • Causa
    The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
  • Acción
    Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.
Retiro De Equipo (Recall) de Biomet RINGLOC Instrumentation Impactor Plate
  • Tipo de evento
    Recall
  • ID del evento
    45987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0703-2008
  • Fecha de inicio del evento
    2007-10-18
  • Fecha de publicación del evento
    2008-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66624
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Acetabular Inserter Instrument - Product Code LXH
  • Causa
    The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
  • Acción
    Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.
Retiro De Equipo (Recall) de Biomet RINGLOC Instrumentation Impactor Plate
  • Tipo de evento
    Recall
  • ID del evento
    45987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0704-2008
  • Fecha de inicio del evento
    2007-10-18
  • Fecha de publicación del evento
    2008-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66625
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Acetabular Inserter Instrument - Product Code LXH
  • Causa
    The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
  • Acción
    Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.
Retiro De Equipo (Recall) de Biomet RINGLOC Instrumentation Impactor Plate
  • Tipo de evento
    Recall
  • ID del evento
    45987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0705-2008
  • Fecha de inicio del evento
    2007-10-18
  • Fecha de publicación del evento
    2008-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66626
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Acetabular Inserter Instrument - Product Code LXH
  • Causa
    The instrument will not lock onto the impactor handle; the device was distributed without assembly of the bal seal component.
  • Acción
    Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.
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