Events

Retiro De Equipo (Recall) de Smith & Nephew Osteotome

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Smith & Nephew Inc.

¿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
    21690
  • Fecha de inicio del evento
    2017-07-14
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • Causa
    The manufacturer has become aware that the affected devices are labelled with expiration dates based on a 10 year packaging shelf-life where the actual validated shelf life of the outer pouch packaging is 5 years. this could potentially result in the outside of the inner tray packaging being non-sterile, potentially contaminating the sterile field.
  • Acción
    Product to be exchanged

Device

Smith & Nephew Osteotome
  • Modelo / Serial
    Model: , Affected: Thin and Radial Osteotome Blades (Model and Batch specific)
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc