Events

Retiro De Equipo (Recall) de Acetabular Cup Introducer (32mm)

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 Synthes.

¿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-2017-RN-01385-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-03
  • 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-2017-RN-01385-1
  • 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 (jjm) has identified an issue with the acetabular cup introducer (32mm) where the nylon ejector slug may melt during the autoclave process. this may cause the ejector to be inoperable and the cup introducer to be difficult to remove after cup placement.
  • Acción
    JJM is requesting Customers: 1. Immediately inspect the device(s) in your possession to determine if your facility has affected product. If you do please quarantine this product prior to returning it to JJM; 2. Return a copy of the supplied acknowledgement form, even if you do not have any affected product, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com; 3. Return any affected product as soon as possible, but within 30 business days, by contacting JJM Customer Service on 1300 562 711; 4. Forward the recall notice to anyone in your facility who needs to be informed; and 5. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable).

Device

Acetabular Cup Introducer (32mm)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes