Events

Retiro De Equipo (Recall) de TRIATHLON TIBIAL ALIGNMENT HANDLE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por STRYKER CANADA LP.

¿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
    45981
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-10-12
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Stryker received a product experience report (per) that a swivel block was improperly oriented on a triathlon tibial alignment handle. the locator holes on the alignment guide handle on which the swivel block is mounted are not in alignment as per print. the tibial alignment handle was not machined properly on the 5 axis machine because the tibial alignment handle was not fixtured properly on the machine by the operator. the fixturing procedure involved manually locating every part in a collet aligning datum c using a square and locking the part in position for machining of the slot and cross hole. additionally the particular feature was not inspected during in-process and/or final inspection at the vendor. hence the non-conformance was not detected.

Device

TRIATHLON TIBIAL ALIGNMENT HANDLE
  • Modelo / Serial
    Model Catalog: I-K2072AHOO (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6541-2-807 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6541-2-808 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    TRIATHLON TIBIAL ALIGNMENT HANDLE
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC