Retiro De Equipo (Recall) de Samarys Peek Anterior Cervical Cage

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por B Braun Australia Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    This hazard alert is being issued because of a random non-conformity relevant to the gold wires used as a position marker for the cervical peek cage samarys. the observed facts were that some devices within 4 lots manufactured between april 2014 and november 2015 presented missing, improperly secured, and/or incorrectly positioned gold wire markers, which may protrude 1-2 mm inside or outside the cage.Gold wires protruding from cage may cause local inflammation and/or neural or vascular injuries at treated site or distant ones by migration (in complete protrusion), which potentially can have serious consequences. the probability of these potential adverse events is however very low. to date, no customer complaint has been recorded and no adverse event or incident has been reported.
  • Acción
    The sponsor is advising the surgeons that in the case of improper fixation of the gold wire, migration of these small dimensioned gold wires in the surrounding tissues would be easily detected on the X-ray films that are routinely taken during patient follow-up. Additionally, as exposed subjects may be often asymptomatic for a long period, surgeons must check on the routine X-ray films that position markers did not migrate. They may also warn implanted patients to report any late dysphagia, sensation of foreign bodies into their throat or suspect cough or different concerning symptoms, as this might allow early detecting a potential complication and solving it. For further information, please see This action has been closed-out on 30/08/2016.


  • Modelo / Serial
    Samarys Peek Anterior Cervical CageUnits from the following batches of Samarys Peek Anterior Cervical Cage are affected.Part No: 11CC2A15-5S Lot No:23LJ-19196Part No: 11CC2A17-6S Lot No: 23KY+19029Part No: 11CC2AC17-5S Lot No: 247P+19029Part No: 11CC2AC17-6S Lot No: 248K+19029ARTG Number: 101789
  • Manufacturer