Events

Retiro De Equipo (Recall) de DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

¿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
    RC-2013-RN-00482-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-04
  • 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-2013-RN-00482-1
  • 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
    Johnson & johnson medical pty ltd (jjm) has identified the potential for the reclaim reamer extension tabs to break off. 9 complaints worldwide since 2011 have been received reporting tab breakage. none of the complaints have indicated fragments were left in patients.
  • Acción
    JJM is advising that users should check the condition of the reamer extension tabs on a regular basis, especially before and after usage. Any reamer extensions showing signs of cracks in the tab area or having broken or missing tabs, should be returned to JJM. Other devices from the affected lots may continue to be used until a design change is implemented and new devices are available.

Device

DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)
  • Modelo / Serial
    DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)Part Number: 297500500Lot Numbers: J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586. NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023 ARTG Number: 191616
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia