Events

Retiro De Equipo (Recall) de TRIGEN TITANIUM NAIL SYSTEM - INTERTAN SHORT NAILS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITH & NEPHEW INC..

¿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
    93967
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-04-08
  • 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
    Smith & nephew has initiated a product recall of several batches of the trigen intertan nail due to a manufacturing error which resulted in the set screw being set too deep in the affected nails. during implantation when the proximal femur is being reamed to accept the lag and compression screw the reamer may impinge the set screw causing potential breakage of the reamer.

Device

TRIGEN TITANIUM NAIL SYSTEM - INTERTAN SHORT NAILS
  • Modelo / Serial
    Model Catalog: 71675202 (Lot serial: 13LT37010); Model Catalog: 71675204 (Lot serial: 13LT37010); Model Catalog: 71675205 (Lot serial: 13LT37010); Model Catalog: 71675211 (Lot serial: 13LT37010); Model Catalog: 71675201 (Lot serial: 13LT37010); Model Catalog: 71675201 (Lot serial: 13LT36306); Model Catalog: 71675202 (Lot serial: 13LT37012); Model Catalog: 71675201 (Lot serial: 13LT37012); Model Catalog: 71675211 (Lot serial: 13LT36308); Model Catalog: 71675205 (Lot serial: 13LT36308); Model Catalog: 71675204 (Lot serial: 13LT36308); Model Catalog: 71675202 (Lot serial: 13LT36308); Model Catalog: 71675201 (Lot serial: 13LT36308); Model Catalog: 71675211 (Lot serial: 13LT36306); Model Catalog: 71675205 (Lot serial: 13LT36306); Model Catalog: 71675204 (Lot serial: 13LT36306); Model Catalog: 71675202 (Lot serial: 13LT36306); Model Catalog: 71675211 (Lot serial: 13LT36313); Model Catalog: 71675205 (Lot serial: 13LT36313); Model Catalog: 71675204 (Lot serial: 13LT36313); Model Catalog: 71675204 (Lot serial: 13LT37
  • Descripción del producto
    TRIGEN TITANIUM NAIL SYSTEM - INTERTAN SHORT NAILS
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    HC