Events

Retiro De Equipo (Recall) de Stryker Torque Wrench

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 Spine SAS.

¿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
    16051
  • Fecha de inicio del evento
    2014-01-22
  • 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 previously initiated a lot specific recall (ref #15444) after reports received that the hex tip of the torque wrench of an identified lot number subset had been fracturing during final tightening.The establised cause for the fracture was due to grain boundary attack as a result of the heat treat process. since that time additional testing has continued and the manufacturer has made the decision to distribute a recall letter to all customers that have a procedure pack in their possession that may contain the affected product and inform them of the recall expansion. additionally the manufacturer has confirmed that the supplier will use a new heat treatment vendor for which there is a validated heat treatment process., 31/07/2015 - identified that lot 11e035 was not previous included in the recall letters associated with this recall. recall letter updated to include all affected lots and attached a list of all current locations.
  • Acción
    Product to be returned to supplier

Device

Stryker Torque Wrench
  • Modelo / Serial
    Model: Xia 03807028, Xia 3 48237028, Mantis Redux 48287028, Affected: 092793, 098525, 11A957, 11E035, 11E039, 11E042, 11E045, 11E046, 11E047 , 123746, 127051 and R11E036
  • Manufacturer
    Stryker Spine SAS

Manufacturer

Stryker Spine SAS
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA