Events

Retiro De Equipo (Recall) de SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system)

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-01520-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-21
  • 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-01520-1
  • 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
    There is the potential that the affected lot of the synream flexible shaft may have been manufactured with a non-symmetric hexagonal coupling which may result in the reamer shaft not fitting into the reamer heads. in the event that the flexible shaft cannot be assembled with the reamer head, surgical delay may occur if another device is not available in the surgical suite.
  • Acción
    JJM is advising customers to immediately quarantine affected product, and then contact JJM who will arrange for return of the product and replacement. This action has been closed-out on 11/05/2017.

Device

SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary r...
  • Modelo / Serial
    SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system)Part Number: 352.040Lot Number: 9946822The SynReam Flexible Shaft may be contained within the following two kitsLS SynReamKit Number: ZXAUTR1671 Equipment Number: 3000072587 SynReam Kit Number: ZXAUTR2316Equipment Number: 3000108391ARTG Number: 153666
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes