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  • Dispositivo 2
  • Fabricante 2
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Laparoscopic Trocar - Endosphere
  • Tipo de evento
    Recall
  • ID del evento
    R1809641
  • Fecha
    2018-06-14
  • 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/trocart-de-coelioscopie-endosphere-peters-surgical-rappel
  • 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
    The ANSM has been informed of the implementation of a withdrawal of lots made by the company PETERS Surgical .. The users concerned have received the attached mail (14/06/2018) (102 KB). This safety action is registered at ANSM under the number R1809641.
Retiro De Equipo (Recall) de Xpert Reagent C.Difficile BT
  • Tipo de evento
    Recall
  • ID del evento
    R1809653
  • Fecha
    2018-07-25
  • 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/bacteriologie-reactif-xpert-c-difficile-bt-cepheid-rappel-de-lot
  • 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 the withdrawal of a lot made by CEPHEID. The users concerned have received the attached mail (25/07/2018) (63 KB). This safety action is registered at ANSM under the number R1809653, R1811069.
Retiro De Equipo (Recall) de Infinite Thread® Reusable Needles
  • Tipo de evento
    Recall
  • ID del evento
    R1809721
  • Fecha
    2018-07-04
  • 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/esthetique-autre-aiguilles-reutilisables-infinite-thread-r-thread-lift-rappel
  • 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
    The ANSM has been informed of the implementation of a safety action / withdrawal of batch / withdrawal of product by the company Thread & Lift .. The users concerned have received the attached mail. (04/07/2018) (65 KB) This security action is registered with the ANSM under the number R1809721.
Retiro De Equipo (Recall) de Reactive - Na + Plates VITROS Chemistry Products
  • Tipo de evento
    Recall
  • ID del evento
    R1809787
  • Fecha
    2018-06-20
  • 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/reactif-plaques-na-vitros-chemistry-products-ortho-clinical-diagnostics-rappel
  • 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
    The ANSM has been informed of the implementation of a lot withdrawal carried out by ORTHO CLINICAL DIAGNOSTICS. The users concerned have received the attached mail (20/06/2018) (262 KB). This safety action is registered with the ANSM under the number R1809787.
Retiro De Equipo (Recall) de 4 in 1 MC and KYN - C2F Femoral Cutting Guide Implants
  • Tipo de evento
    Recall
  • ID del evento
    R1809794
  • Fecha
    2018-06-14
  • 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/orthopedie-guide-de-coupe-femoral-4-en-1-mc-et-kyn-c2f-implants-rappel
  • 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
    The ANSM has been informed of the implementation of a lot withdrawal action carried out by the company C2F IMPLANTS. The users concerned have received the attached mail (14/06/2018) (319 KB). This safety action is registered at ANSM under the number R1809794.
Retiro De Equipo (Recall) de Device Recall Stryker Recon, Radial Implant, Standard Stem
  • Tipo de evento
    Recall
  • ID del evento
    71676
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2429-2015
  • Fecha de inicio del evento
    2015-06-24
  • Fecha de publicación del evento
    2015-08-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138752
  • 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
    Prosthesis, elbow, semi-constrained, cemented - Product Code JDB
  • Causa
    Stryker is recalling rhead, uhead, sigmoid notch, remotion, radio capitellum because packaging integrity (sterile barrier) of the packaging type kit i may potentially be compromised by transportation.
  • Acción
    Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.
Retiro De Equipo (Recall) de UL 7801-62 Retractors
  • Tipo de evento
    Recall
  • ID del evento
    R1809835
  • Fecha
    2018-06-19
  • 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/ecarteurs-ul-7801-62-ulrich-medical-rappel-de-lots
  • 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
    The ANSM has been informed of the implementation of a batch withdrawal carried out by ULRICH MEDICAL. The users concerned have received the attached mail (19/06/2018) (108 KB). This safety action is registered with the ANSM under the number R1809835.
Retiro De Equipo (Recall) de Accu Chek Performa Strips
  • Tipo de evento
    Recall
  • ID del evento
    R1809908
  • Fecha
    2018-06-21
  • 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/autosurveillance-glycemique-bandelettes-accu-chek-performa-roche-diabetes-care-inter-trade-pharma-rappel
  • 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 batch withdrawal carried out by Inter Trade Pharma. The pharmacies and wholesalers concerned received the attached mail, along with a letter to the patients. mail for pharmacies (21/06/2018) (91 KB mail for wholesalers (21/06/2018) (88 KB mail for patients (21/06/2018)) (51 KB. is registered at ANSM under the number R1809908.
Retiro De Equipo (Recall) de Safil and Novosyn
  • Tipo de evento
    Recall
  • ID del evento
    R1809923
  • Fecha
    2018-06-14
  • 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/fil-de-suture-chirurgicale-safil-and-novosyn-b-braun-medical-rappel
  • 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
    The ANSM has been informed of the implementation of a lot withdrawal carried out by the company B BRAUN MEDICAL .. The users concerned have received the attached mail (14/06/2018) (6867 ko). This safety action is registered with the ANSM under the number R1809923.
Retiro De Equipo (Recall) de Hydroline Trumpet Valve
  • Tipo de evento
    Recall
  • ID del evento
    R1809926
  • Fecha
    2018-06-22
  • 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/instrumentation-coelioscopique-hydroline-trumpet-valve-cardinal-health-rappel
  • 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
    The ANSM has been informed of the implementation of a withdrawal of lots made by the company CARDINAL HEALTH .. The users concerned have received the attached mail. (22/06/2018) (57 KB) This safety action is registered with the ANSM under the number R1809926.
Retiro De Equipo (Recall) de Rollator Quava Rollator
  • Tipo de evento
    Recall
  • ID del evento
    R1809955
  • Fecha
    2018-06-15
  • 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/deambulateur-rollator-quava-vermeiren-group-sa-rappel
  • 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 lot withdrawal carried out by Vermeiren Group (SA). The users concerned received the attached mail (15/06/2018) (123 KB). This safety action is registered at ANSM under the number R1809955.
Retiro De Equipo (Recall) de Device Recall Stryker Sigmoid Notch, Radial Plate
  • Tipo de evento
    Recall
  • ID del evento
    71676
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2430-2015
  • Fecha de inicio del evento
    2015-06-24
  • Fecha de publicación del evento
    2015-08-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138753
  • 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
    Prosthesis, wrist, hemi-, ulnar - Product Code KXE
  • Causa
    Stryker is recalling rhead, uhead, sigmoid notch, remotion, radio capitellum because packaging integrity (sterile barrier) of the packaging type kit i may potentially be compromised by transportation.
  • Acción
    Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.
Retiro De Equipo (Recall) de Impix Manta
  • Tipo de evento
    Recall
  • ID del evento
    R1810013
  • Fecha
    2018-06-22
  • 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/chirurgie-du-rachis-cage-intersomatique-impix-manta-pre-remplie-et-montee-sur-prehenseur-medicrea-international-rappel
  • 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
    The ANSM has been informed of the implementation of a lot withdrawal action carried out by MEDICREA INTERNATIONAL. The users concerned have received the attached letter (22/06/2018) (174 KB). This safety action is registered at ANSM under the number R1810013.
Retiro De Equipo (Recall) de Ironmag Reagent
  • Tipo de evento
    Recall
  • ID del evento
    R1810071
  • Fecha
    2018-06-25
  • 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/reactif-ironmag-diagast-rappel-de-lot
  • 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
    The ANSM has been informed of the implementation of the withdrawal of a lot made by DIAGAST. The users concerned have received the attached mail. (25/06/2018) (63 KB) This security action is registered with the ANSM under the number R1810071.
Retiro De Equipo (Recall) de Antibiotic discs SIRSCAN® DISCS Amoxicillin 2μg + Clavulanic acid 1μg
  • Tipo de evento
    Recall
  • ID del evento
    R1810128
  • Fecha
    2018-07-19
  • 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/bacteriologie-disques-antibiotiques-sirscan-r-discs-amoxicilline-2-g-acide-clavulanique-1-g-i2a-rappel
  • 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 lot withdrawal carried out by I2A - Artificial Intelligence Applications SA. The affected users received the attached mail (19/07/2018) (122 KB). This safety action is registered at ANSM under the number R1810128.
Retiro De Equipo (Recall) de Scultra II
  • Tipo de evento
    Recall
  • ID del evento
    R1810156
  • Fecha
    2018-06-22
  • 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/tige-humerale-cimentee-scultra-ii-standard-euros-rappel
  • 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
    The ANSM has been informed of the implementation of a lot withdrawal action carried out by the company EUROS .. The users concerned have received the attached mail (22/06/2018) (747 ko). This safety action is registered with the ANSM under the number R1810156.
Retiro De Equipo (Recall) de Bond ™ Polymer Refine Detection Reagent
  • Tipo de evento
    Recall
  • ID del evento
    R1810177
  • Fecha
    2018-07-03
  • 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/reactif-bond-polymer-refine-detection-leica-biosystems-rappel
  • 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 batch withdrawal carried out by the company LEICA BIOSYSTEMS .. The users concerned have received the attached mail. (03/07/2018) (4534 kb.) This safety action is registered at the ANSM under the number R1810177.
Retiro De Equipo (Recall) de Device Recall da Vinci Si Surgical System IS3000, Monitor Drape
  • Tipo de evento
    Recall
  • ID del evento
    70777
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1386-2015
  • Fecha de inicio del evento
    2015-03-16
  • Fecha de publicación del evento
    2015-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134704
  • 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
    Drape, surgical - Product Code KKX
  • Causa
    Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
  • Acción
    Firm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication.
Retiro De Equipo (Recall) de Liquid Nitrogen Tank - Cryogenic Aluminum Tanks
  • Tipo de evento
    Recall
  • ID del evento
    R1810240
  • Fecha
    2018-06-27
  • 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/bonbonne-d-azote-liquide-cuves-cryogeniques-en-aluminium-cryo-diffusion-rappel
  • 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 batch withdrawal carried out by the company CRYO DIFFUSION. The users concerned have received the attached mail. (27/06/2018) (613 KB) This safety action is registered with the ANSM under the number R1810240.
Retiro De Equipo (Recall) de Corail® Standard cementless femoral stem without collar
  • Tipo de evento
    Recall
  • ID del evento
    R1810243
  • Fecha
    2018-07-02
  • 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/prothese-totale-de-hanche-tige-femorale-orthopedie-tige-femorale-sans-ciment-corail-r-standard-sans-collerette-depuy-france-rappel
  • 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
    The ANSM has been informed of the implementation of a lot withdrawal action carried out by the company DePuy France .. The users concerned have received the attached mail (02/07/2018) (187 KB). This safety action is registered with the ANSM under the number R1810243.
Retiro De Equipo (Recall) de Journey Bcs Knee Prosthesis System
  • Tipo de evento
    Recall
  • ID del evento
    R1810245
  • Fecha
    2018-06-27
  • 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/orthopedie-systeme-de-prothese-de-genou-journey-bcs-smith-nephew-rappel
  • 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
    The ANSM has been informed of the implementation of a safety action and product withdrawal carried out by SMITH & NEPHEW. The users concerned have received the attached letter (27/06/2018) (75 KB) ). This safety action is registered at ANSM under the number R1810245.
Retiro De Equipo (Recall) de Various nail guides Trauma
  • Tipo de evento
    Recall
  • ID del evento
    R1810338
  • Fecha
    2018-06-27
  • 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/traumatologie-divers-guides-clous-trauma-biomet-zimmer-rappel
  • 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
    The ANSM has been informed of the implementation of a lot withdrawal action carried out by BIOMET ZIMMER. The users concerned have received the attached letter (27/06/2018) (118 KB). This safety action is registered with the ANSM under the number R1810338.
Retiro De Equipo (Recall) de Hydroline Irrigation / Inlet Pumps
  • Tipo de evento
    Recall
  • ID del evento
    R1810401
  • Fecha
    2018-06-29
  • 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/instrumentation-coelioscopique-canules-a-piston-pour-irrigation-aspiration-hydroline-cardinal-health-medline-rappel
  • 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
    The ANSM has been informed of the implementation of a lot withdrawal by Medline. The users concerned have received the attached letter. (29/06/2018) (33 KB) This security action is registered with the ANSM under the number R1810401.
Retiro De Equipo (Recall) de Device Recall GEMINI TF 16 Slice CT/PET System
  • Tipo de evento
    Recall
  • ID del evento
    71699
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2195-2015
  • Fecha de inicio del evento
    2015-07-01
  • Fecha de publicación del evento
    2015-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138770
  • 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
    System, tomography, computed, emission - Product Code KPS
  • Causa
    Philips has identified four (4) software defects in the tumor loc software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
  • Acción
    On 7/6/2015 the firm sent Field Safety Notices to their customers.
Retiro De Equipo (Recall) de Surgical suture Polysorb braided suture suture Covidien CL-955
  • Tipo de evento
    Recall
  • ID del evento
    R1810404
  • Fecha
    2018-06-29
  • 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/fil-de-suture-chirurgicale-polysorb-suture-resorbable-tressee-covidien-cl-955-medtronic-retrait-de-de-lot
  • 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 lot withdrawal by Medtronic. The users concerned received the attached mail (29/06/2018) (131 KB). This safety action is registered with the ANSM under the number R1810404.
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