Events

Retiro De Equipo (Recall) de PILOT DRILL STAINLESS STEEL

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

¿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
    16421
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-28
  • 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
    The investigation of a complaint has confirmed that the shaft diameter of a drill (article 044.215 lot lv457) is greater than the defined specification of 2.35 mm in the area of the laser marking on the shaft. further investigation has shown that additional articles and lots are impacted. testing with different handpieces demonstrates that the drills can be inserted however depending on the manufacturing tolerances of the handpiece that is used these drills may not fit. the drills are multiple use instruments and are delivered non-sterile. in accordance with ifu 701124 they must be unpacked disinfected cleaned and sterilized before use. additionally the ifu states that "before every use the device has to be carefully checked for proper function and damage." if the drills do not fit into the handpiece and there is not an alternative instrument available then the planned treatment will need to be re-scheduled.

Device

PILOT DRILL STAINLESS STEEL
  • Modelo / Serial
    Model Catalog: 044.210 (Lot serial: LV457); Model Catalog: 044.214 (Lot serial: MH027); Model Catalog: 044.210 (Lot serial: MH027); Model Catalog: 044.215 (Lot serial: LV463); Model Catalog: 044.214 (Lot serial: LV463); Model Catalog: 044.210 (Lot serial: LV463); Model Catalog: 044.215 (Lot serial: LV457); Model Catalog: 044.214 (Lot serial: LV457); Model Catalog: 044.210 (Lot serial: MJ330); Model Catalog: 044.214 (Lot serial: MJ330); Model Catalog: 044.215 (Lot serial: MJ330); Model Catalog: 044.255 (Lot serial: LV455); Model Catalog: 044.215 (Lot serial: MH027)
  • Descripción del producto
    PILOT DRILL - STAINLESS STEEL;TWIST DRILL - STAINLESS STEEL
  • Manufacturer
    STRAUMANN CANADA LIMITED

Manufacturer

STRAUMANN CANADA LIMITED