Events

Retiro De Equipo (Recall) de Device Recall Target Detachable Coils

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Stryker Neurovascular.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    74425
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2172-2016
  • Fecha de inicio del evento
    2016-06-06
  • Fecha de publicación del evento
    2016-07-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147561
  • 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
    Device, neurovascular embolization - Product Code HCG
  • Causa
    Stryker neurovascular has become aware that some units of target nano product do not have the intended stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
  • Acción
    Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.

Device

Device Recall Target Detachable Coils
  • Modelo / Serial
    MODEL Number: M0035442030:  Lot Number/Expiration Date: 18824618 31-Jan-19 18789433 31-Jan-19 18789313 31-Jan-19 18567759 31-Aug-18 18809910 31-Jan-19 18758958 31-Dec-18 18727834 30-Nov-18 18643654 31-Oct-18 18583601 31-Aug-18 18516768 31-Jul-18 18440858 30-Jun-18 18824978 31-Jan-19 18770574 31-Dec-18 18679027 30-Nov-18 18654466 31-Oct-18 18554671 31-Aug-18 18727594 30-Nov-18 18702335 30-Nov-18 18679058 30-Nov-18 18554733 31-Aug-18 18583632 30-Sep-18 18824858 31-Jan-19 18816099 31-Jan-19 18789193 31-Jan-19 18770164 31-Dec-18 18721125 30-Nov-18 18667475 31-Oct-18 18470167 31-Jul-18 18440828 30-Jun-18 18770369 31-Dec-18 18758838 31-Dec-18 18740007 31-Dec-18 18654404 31-Oct-18 18515390 31-Jul-18 18824738 31-Jan-19 18789553 31-Jan-19 18727714 30-Nov-18 18567790 31-Aug-18 18489524 31-Jul-18 18462508 30-Jun-18 18434346 30-Jun-18 18810270 31-Jan-19 18810150 31-Jan-19 18810030 31-Jan-19 18816010 31-Jan-19 18740154 31-Dec-18 18715530 30-Nov-18 18702304 30-Nov-18 18654497 31-Oct-18 18437093 30-Jun-18 18437033 30-Jun-18 18992597 30-Apr-19 19071307 31-May-19 18946838 31-Mar-19 18897907 28-Feb-19 18869664 28-Feb-19 18847712 31-Jan-19 18992628 30-Apr-19 19045040 31-May-19 19044951 31-May-19 19071071 31-May-19 19014571 30-Apr-19 18933425 31-Mar-19 18933692 31-Mar-19 18947016 31-Mar-19 18897814 28-Feb-19 18869810 28-Feb-19 18881694 28-Feb-19 19054629 31-May-19 19054753 31-May-19 19014726 30-Apr-19 18869869 31-Mar-19 18881787 28-Feb-19 18848068 31-Jan-19 19044862 31-May-19 19014602 30-Apr-19 18976136 30-Apr-19 18961238 31-Mar-19 18911301 28-Feb-19 18933603 31-Mar-19 19045129 31-May-19 19014664 30-Apr-19 18961118 31-Mar-19 18947105 31-Mar-19 18946927 31-Mar-19 18897876 28-Feb-19 18869748 28-Feb-19 18881725 28-Feb-19 18992659 30-Apr-19 19054691 31-May-19 19030837 30-Apr-19 19054815 31-May-19 19065247 31-May-19 19071543 31-May-19 19014633 30-Apr-19 18976225 30-Apr-19 18976047 30-Apr-19 18911332 28-Feb-19 18869954 28-Feb-19 18881663 28-Feb-19 18881756 28-Feb-19 19054877 31-May-19 19030570 30-Apr-19 19030481 30-Apr-19 19014695 30-Apr-19 18975958 30-Apr-19 18897938 28-Feb-19 18950354 31-Mar-19 18946749 31-Mar-19 18897845 28-Feb-19 19030926 30-Apr-19 18992690 30-Apr-19 19030659 30-Apr-19 19045218 31-May-19 18933514 31-Mar-19 18950416 31-Mar-19 18933336 31-Mar-19 18911270 28-Feb-19 18848246 28-Feb-19 18847890 28-Feb-19.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
  • Descripción del producto
    Target Detachable Coils: || TARGET 360 NANO 2MM X 3CM || MODEL Number:M0035442030 || Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Dirección del fabricante
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA