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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Retiro De Equipo (Recall) de CLAW and CLAW II Plates (An internal fixation device for the stabili...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00914-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-27
  • 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-2014-RN-00914-1
  • 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
    As an outcome of an investigation from a field complaint, wright medical discovered that certain claw and claw ii plates were manufactured from an incorrect raw material. the raw material specified for claw and claw ii plates is stainless steel meeting the requirements of astm f139 in a cold worked condition, however the material used meets the requirements of astm f139 stainless steel, but is in an annealed condition, which has reduced strength and increased ductility.
  • Acción
    Wright Medical is recalling affected stock from hospitals. Additionally, Wright Medical is advising surgeons that if the intended postoperative instructions are followed by the patient, the product will still perform as intended. If the patient does not follow instructions and bears weight on the plate prior to fusion the ductility of the material may increase the likelihood of malunion or non-union. Prophylactic revision surgery is not recommended. For more details, please see http://www.tga.gov.au/safety/alerts-device-claw-plates-140829.htm . This action has been closed-out on 16/05/2017.
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 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
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 Application Instrument for Sternal ZIPFIX(Sternal ZIPFIX is used for...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00897-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-09-15
  • 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-2015-RN-00897-1
  • 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
    In the affected lots of the application instrument for sternal zipfix :· the end cap may loosen, thus reducing the tension applied to the implant. · the end cap may detach, allowing the tensioning spring to also become detached, making the instrument non-functional.If the end cap is loose, the maximum tension applied to the implant is reduced and may lead to insufficient sternal bone reduction. if the tension coil spring detaches completely from the zipfix application instrument while closing the sternum, it is possible that the spring or nut could fall into the thoracic cavity and go undetected. if the nut/spring is retained in the thoracic cavity, adverse tissue reaction may occur. no such occurrence has been reported to date.
  • Acción
    Customers are requested to immediately check their inventory to determine if the facility has any affected product and if so to quarantine those units prior to returning them to JJM for repair. This action has been closed-out on 05/09/2016.
Retiro De Equipo (Recall) de Medtronic Spinous Process Clamps
  • Tipo de evento
    Recall
  • ID del evento
    RC-2017-RN-00864-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-07-18
  • 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-00864-1
  • 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
    Medtronic has become aware of instances where spine clamps have been damaged when forced open beyond their intended limits during use and will subsequently not open once attached to a patient’s spinous process. when the spine clamp is forced open beyond its intended limits, a component (captive washer) may break off. the washer could then be inadvertently left behind in a patient’s body if the breakage occurs during the procedure. if the washer is missing from the device, the spine clamp cannot be re-opened after placement on the spinous process.Medtronic has received six reports where unintended removal of spinous process occurred when attempting to detach the spine clamp. the unintended removal of spinous process can lead to damage of adjacent vertebra and cause premature degradation.
  • Acción
    Medtronic is providing an interim workaround for users via the Customer Letter. A new version of the clamps with a design mitigation will be distributed as a permanent correction once available.
Retiro De Equipo (Recall) de PROFEMUR® NECK VAR/VAL 8DG
  • Tipo de evento
    Recall
  • Fecha
    2015-08-31
  • 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%202015/31-8-2015/PROFEMUR%C2%AENECKVARVAL8DG.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 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 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
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