Events

Retiro De Equipo (Recall) de Stryker Orthopaedics Prosthesis, internal, joint, knee, tibial component

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 Stryker Howmedica Osteonics.

¿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
    13559
  • Fecha de inicio del evento
    2012-10-04
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    Manufacturer has become aware of potential packaging issue associated with various products. initial inspections of some items (as listed) revealed what the manufacturer refers to as “creep”. this is when the sterile barrier surface area decreases. at this point, no units have been found to have a full breach of the seal., technical and medical assessments are currently underway to determine any potential hazards associated with the use of the product. all product to be returned to the manufacturer.
  • Acción
    Product to be returned to supplier

Device

Stryker Orthopaedics Prosthesis, internal, joint, knee, tibial component

Manufacturer

Stryker Howmedica Osteonics
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA