Events

Retiro De Equipo (Recall) de Nitinol Staples Elastic Staples - Large and Small Symmetrical

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por LMT Surgical Pty Ltd.

¿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-2018-RN-00354-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-26
  • 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-2018-RN-00354-1
  • 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
    During a retrospective review of sterilisation records, trimed has determined that evidence of quarterly dose audits/verification required to comply with the relevant regulations could not be found. sterilization records indicate that all lots of staples were irradiated to at least the defined dose and although trimed has not received any reports of adverse events or injuries, there is a risk that this issue could result in patient infection if not properly sterilised.
  • Acción
    As a permanent corrective action, TriMed will recall all of the Nitinol Staples that were manufactured between March 12, 2015 to the present date.

Device

Nitinol Staples Elastic Staples - Large and Small Symmetrical
  • Modelo / Serial
    Nitinol StaplesElastic Staples - Large and Small SymmetricalMultiple Model and Lot NumbersPanel Code: 87 Orthopedic, Part 888.3030Product Code: JDRAll staples manufactured between March 12, 2015 - presentARTG Number: 229705LMT Surgical - Fixation device, internal, staple
  • Manufacturer
    LMT Surgical Pty Ltd

Manufacturer

LMT Surgical Pty Ltd