Events

Retiro De Equipo (Recall) de Trauma RIA (Reamer/Irrigator/Aspirator) System Part Affected; RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterile

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-2016-RN-01645-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-23
  • 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-2016-RN-01645-1
  • 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
    The expiration date on the label for the referenced products is incorrect. existing testing supports an expiration date of 2 years from manufacturing. the affected products on the market were labelled with an expiration date of 10 years. there is biocompatibility test data to support an expiration date 2 years only.Use of this product beyond its expiry date of 2 years poses a theoretical risk of an adverse tissue reaction in the event the device develops cytotoxicity and/or infection.
  • Acción
    Johnson & Johnson Medical (JJM) is requesting users Immediately inspect the device(s) in their possession to determine if your facility has affected product. In the event defective product is identified please quarantine these units prior to returning them to JJM. Return a copy of the completed acknowledgement form, even if no affected product is identified, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com

Device

Trauma RIA (Reamer/Irrigator/Aspirator) System Part Affected; RIA Tube Assembly, for RIA Drive Sh...
  • Modelo / Serial
    Trauma RIA (Reamer/Irrigator/Aspirator) SystemPart Affected; RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterilePart Number : 314.746SLot Numbers: 2251446-I, 2256902-I, 2256903-I, 2256904-I, 2256905-I, 2256906-I, 2256907-IARTG Number: 157016
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes