Events

Retiro De Equipo (Recall) de DePuy Synthes Trauma DHS/DCS Impactor TipInsert for DHS/DCS Impactor No. 338.280, Single

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-00184-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-05
  • 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-00184-1
  • 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 dhs/dcs impactor is composed of two parts: a replaceable plastic tip which is the insert for dhs/dcs impactor (338.260), and a metallic shaft (338.280). no biocompatibility testing has ever been completed by the manufacturer, synthes for the material (polyamide 6.6 with 20% carbon fibre reinforcement, tecamid 66 cf 20) for the insert and no evidence was found that it has been completed by other entities. potential for harm exists due to the potential for device breakage and may include surgical delay and adverse tissue reaction.
  • Acción
    Johnson & Johnson Medical is replacing the plastic tip of the insert with a metal tip. Once the redesigned tip is available Johnson & Johnson Medical will arrange for the recovery and replacement of the old impactor tip. In the interim to ensure the impactor is available for emergency surgery, Johnson & Johnson Medical has provided end users with inspection instructions to check for any wear and tear. Alternatively, hospitals can return the tip for a credit note. This action has been closed out on 14 June 2017.

Device

DePuy Synthes Trauma DHS/DCS Impactor TipInsert for DHS/DCS Impactor No. 338.280, Single
  • Modelo / Serial
    DePuy Synthes Trauma DHS/DCS Impactor TipInsert for DHS/DCS Impactor No. 338.280, SinglePart number: 338.260All lot numbers below 7985313DHS/DCS & Impactor, for One-Step Insertion Technique, for No. 338.300Part number: 338.280All lot numbers below 8016184 ARTG number 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes