Events

Retiro De Equipo (Recall) de Synthes Craniomaxillofacial (CMF) Distraction System, BC Distraction Bodies

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 Synthes GmbH.

¿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
    16596
  • Fecha de inicio del evento
    2014-05-14
  • 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: Synthes New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, Auckland 1060
  • Causa
    The ab and bc distractor bodies used in the craniomaxillofacial distraction system may reverse post-operatively., in the presence of inadequate distraction or reversal of a previously achieved distraction distance, the patient may need to undergo prolonged distraction therapy. in some instances, revision surgery may be needed to replace the device., reversing occurs when the distractor screw is turned in the opposite direction to cause the assembly to lose distraction distance.
  • Acción
    Product to be returned to supplier

Device

Synthes Craniomaxillofacial (CMF) Distraction System, BC Distraction Bodies
  • Modelo / Serial
    Model: Models: 04.315.064 and 04.315.066, Affected: Lots: 6342004, 7351857 and 6651388, 6913921, 718588 respectivly
  • Clasificación del producto
    Dental Devices
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH