Events

Retiro De Equipo (Recall) de Synream Medullary Reamer Head Size 13.5mm

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-2015-RN-01241-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-18
  • 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-2015-RN-01241-1
  • 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 affected part number and lot number is etched as dimension 13.5mm while the actual dimension is 14mm.If a 14mm reamer head is labelled and etched as a 13.5mm, there is the potential that the surgeon would be advancing 1.0mm versus 0.5mm; thus, there is a risk of the reamer head jamming. surgical delay could occur as the reamer head is removed from the medullary canal and bone debris is removed or the reamer head is replaced with another reamer head. there is also the potential for damage to the bone.
  • Acción
    JJM is advising users to inspect stock and return any of the affected product to JJM for replacement with unaffected stock. This action has been closed-out on 24/08/2016.

Device

Synream Medullary Reamer Head Size 13.5mm

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes