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  • Dispositivo 2
  • Fabricante 2
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de il reagent magnesium test used in the ilab 600/650...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2501
  • Fecha
    2013-06-25
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-instrumentation-laboratory-dotycz%C4%85ca-odczynnika-il-test-magnesium
  • 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
    Instrumentation Laboratory safety note for IL Magnesium test reagent used in ILab 600/650 and ILAB Taurus analyzers
Notificaciones De Seguridad De Campo acerca de ilab taurus systems
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1935
  • Fecha
    2014-05-21
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-instrumentation-laboratory-dotycz%C4%85ca-system%C3%B3w-ilab-taurus
  • 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
    Instrumentation Laboratory safety note regarding ILAB TAURUS Systems
Notificaciones De Seguridad De Campo acerca de ilab taurus systems equipped with an ise module
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1533
  • Fecha
    2015-02-20
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-instrumantation-laboratory-dotycz%C4%85ca-system%C3%B3w-ilab-taurus-wyposa%C5%BConych
  • 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
    Instrumantation Laboratory safety note for ILab Taurus systems equipped with an ISE module
Notificaciones De Seguridad De Campo acerca de sensors for potassium determination in the premier...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1931
  • Fecha
    2011-08-03
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-instrumentation-laboratory-dotycz%C4%85ca-czujnik%C3%B3w-oznaczania-potasu-w
  • 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
    Instrumentation Laboratory safety note for potassium determination sensors on the Premier 4000 GEM analyzer.
Notificaciones De Seguridad De Campo acerca de stent-grafts of the thoracic aorta relay and relay...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1676
  • Fecha
    2014-08-19
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-bolton-medical-dotycz%C4%85ca-stent-graft%C3%B3w-aorty-piersiowej-relay-i-relay
  • 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
    Bolton Medical safety note regarding Relay and Relay NBS thoracic stent grafts
Notificaciones De Seguridad De Campo acerca de v5.1.0 programming and p-16.3.00 parameters on the...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2538
  • Fecha
    2013-10-14
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-instrumentation-laboratory-dotycz%C4%85ca-programowania-v510-i-parametr%C3%B3w-p
  • 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
    Instrumentation Laboratory safety note regarding V5.1.0 programming and P-16.3.00 parameters on the ACL TOP family of analyzers
Notificaciones De Seguridad De Campo acerca de software updates for alignrt systems integrated wi...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    357
  • Fecha
    2018-09-03
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-3004832819-072518-001-c-firmy-vision-rt-dotycz%C4%85ca-aktualizacji-oprogramowania
  • 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
    Security note (3004832819-07 / 25 / 18-001-C) of Vision RT company regarding the updating of AlignRT systems software integrated with the TrueBeam linear accelerator
Notificaciones De Seguridad De Campo acerca de PROFEMUR,PROCOTYL, RIM LOCK „A-Class”, BIOLOX DELTA
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2425
  • Fecha
    2012-10-11
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-wright-medical-technology
  • 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
    Wright Medical Technology safety note
Notificaciones De Seguridad De Campo acerca de surgeon masks
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2227
  • Fecha
    2008-10-15
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/decyzja-o-wycofaniu-z-obrotu-i-z-u%C5%BCywania-masek-chirurg-i-med-tr%C3%B3jwarstwowych-xiantao-xianmeng
  • 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
    Decision to withdraw from the market and use surgeon masks. and three-tier Xiantao Xianmeng Health & Protection Products Ltd (October 15, 2008)
Notificaciones De Seguridad De Campo acerca de cytological brushes
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1188
  • Fecha
    2008-05-09
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-o-wycofaniu-z-obrotu-i-u%C5%BCywania-szczoteczek-cytologicznych-produkcji-yangzhou-yada
  • 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 about the recall and use of cytological brushes produced by Yangzhou Yada Industry Group Corp., China (09/05/2008)
Notificaciones De Seguridad De Campo acerca de CE marking
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2125
  • Fecha
    2008-05-05
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-w-sprawie-zawieszenia-certyfikat%C3%B3w-ce-dotycz%C4%85cych-wyrob%C3%B3w-medycznych-firmy-yangzhou-yada
  • 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 regarding the suspension of CE certificates for medical devices from the Yangzhou Yada Industry Group Corp. (05.05.2008)
Notificaciones De Seguridad De Campo acerca de super ravo zapper
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    771
  • Fecha
    2018-10-26
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/decyzja-w-sprawie-wycofania-z-obrotu-wyrobu-medycznego-super-ravo-zapper-kt%C3%B3rego-wytw%C3%B3rc%C4%85-jest-z
  • 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
    Decision on the withdrawal from the market of the medical device Super Ravo Zapper, which is manufactured by Z-Technology sro, Severovýchodní II 1455/43, 141 00 Praha 4, Czech Republic
Notificaciones De Seguridad De Campo acerca de infusion pumps
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1225
  • Fecha
    2007-03-21
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/pompy-infuzyjne-produkcji-kwapisz-pompy-infuzyjne-notatka-doradcza-21032007-0
  • 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
    Infusion pumps manufactured by "KWAPISZ-POMPY INFUZYJNE" - Advisory note (21.03.2007)
Notificaciones De Seguridad De Campo acerca de injection needles vego fine
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1474
  • Fecha
    2007-10-17
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/list-firmy-zarys-w-sprawie-wstrzymania-obrotu-i-u%C5%BCywania-igiel-iniekcyjnych-vego-fine-17102007
  • 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
    Letter from ZARYS regarding the suspension of circulation and the use of injection needles Vego Fine (17.10.2007)
Notificaciones De Seguridad De Campo acerca de devices for transferring infusion fluids
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2057
  • Fecha
    2014-06-23
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zarys-sp-z-oo-dotycz%C4%85ca-wycofania-z-obrotu-i-z-u%C5%BCywania-niekt%C3%B3rych
  • 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
    Security note from Zarys Sp. z oo regarding the withdrawal from use and use of certain series of devices for transferring infusion fluids (catalog number ZARYS28-IS)
Notificaciones De Seguridad De Campo acerca de pencil point lumbar puncture needles
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1476
  • Fecha
    2008-12-12
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-firmy-zarys-sp-z-oo-o-wycofaniu-igie%C5%82-do-nak%C5%82u%C4%87-l%C4%99d%C5%BAwiowych-pencil-point-produkcji-firmy
  • 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
    The announcement of the company ZARYS Sp. z oo on the withdrawal of Pencil Point lumbar puncture needles manufactured by Exelint International Co. (12.12.2008)
Notificaciones De Seguridad De Campo acerca de ceramic femoral heads biolox option - sizes 28 to 40.
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2273
  • Fecha
    2011-09-20
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-dotycz%C4%85ca-zestawu-ceramicznych-g%C5%82%C3%B3w-ko%C5%9Bci-udowej-biolox-option
  • 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
    Zimmer safety note regarding the Biolox ceramic femoral head set - sizes 28 to 40.
Notificaciones De Seguridad De Campo acerca de dental products
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    333
  • Fecha
    2017-12-12
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-biomet-dotycz%C4%85ca-dodatkowych-instrukcji-u%C5%BCywania-niekt%C3%B3rych
  • 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
    Zimmer Biomet safety note for additional instructions on the use of certain dental products
Notificaciones De Seguridad De Campo acerca de agc da 2000 femoral components
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2126
  • Fecha
    2015-07-07
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-biomet-dotycz%C4%85ca-komponent%C3%B3w-udowych-agc-da-2000
  • 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
    Biomet safety note regarding femoral components AGC DA 2000
Notificaciones De Seguridad De Campo acerca de altius multi-axis screwdriver
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    322
  • Fecha
    2017-05-26
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-biomet-dotycz%C4%85ca-wkr%C4%99taka-do-%C5%9Brub-wieloosiowych-altius-nr
  • 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
    Zimmer Biomet safety note for Altius multiaxial screwdriver (item no. 1200-9216)
Notificaciones De Seguridad De Campo acerca de anesthetic joints
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1412
  • Fecha
    2012-10-09
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-biomet-dotycz%C4%85ca-endoprotezy-stawu-skokowego-aes-produkcji-transysteme
  • 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
    BIOMET safety note regarding the AES arthroplasty endoprosthesis made by Transysteme - JMT Implants SA
Notificaciones De Seguridad De Campo acerca de batteries for pulsavac plus devices
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    594
  • Fecha
    2017-10-17
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-biomet-dotycz%C4%85ca-akumulator%C3%B3w-do-urz%C4%85dze%C5%84-pulsavac-plus
  • 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
    Zimmer Biomet safety note regarding batteries for Pulsavac Plus devices
Notificaciones De Seguridad De Campo acerca de bone cement biomet refobacin plus 40
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1289
  • Fecha
    2012-08-23
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-biomet-dotycz%C4%85ca-cementu-kostnego-biomet-refobacin-plus-40
  • 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
    BIOMET safety note regarding bone cement Biomet Refobacin Plus 40
Notificaciones De Seguridad De Campo acerca de bone cement v biomet
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2391
  • Fecha
    2012-03-05
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-biomet-dotycz%C4%85ca-cementu-kostnego-v-biomet
  • 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
    Biomet safety note regarding bone cement V Biomet
Notificaciones De Seguridad De Campo acerca de ceramic femoral heads biolox option.
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1854
  • Fecha
    2011-09-22
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-dotycz%C4%85ca-ceramicznych-g%C5%82%C3%B3w-ko%C5%9Bci-udowej-biolox-option
  • 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
    Zimmer safety note regarding Ceramic femoral heads Biolox OPTION.
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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.

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