Events

Retiro De Equipo (Recall) de COCR DYNAMIC LOCKING SCREW SELF TAPPING

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

¿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
    45089
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-06-25
  • 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
    Synthes (canada) ltd. is initiating a voluntary recall of all lots of the 3.7mm and 5.0mm dynamic locking screw (dls). the voluntary recall is being initiated following synthes' receipt of customer complaints of 3.7 and 5.0 mm dls breakages at the distal tip of the pin identified after successful healing and during planned implant removal of the whole construct. there have been no reports of permanent impairment associated with the reason for this recall to date. however synthes is aware that significant elongation of surgical time has occurred in planned implant removals which involved a broken dls screw.

Device

COCR DYNAMIC LOCKING SCREW SELF TAPPING
  • Modelo / Serial
    Model Catalog: 09.213.022S (Lot serial: all lots); Model Catalog: 09.223.090S (Lot serial: all lots); Model Catalog: 09.223.085S (Lot serial: all lots); Model Catalog: 09.223.080S (Lot serial: all lots); Model Catalog: 09.223.075S (Lot serial: all lots); Model Catalog: 09.223.070S (Lot serial: all lots); Model Catalog: 09.223.065S (Lot serial: all lots); Model Catalog: 09.223.060S (Lot serial: all lots); Model Catalog: 09.223.058S (Lot serial: all lots); Model Catalog: 09.223.056S (Lot serial: all lots); Model Catalog: 09.223.055S (Lot serial: all lots); Model Catalog: 09.223.054S (Lot serial: all lots); Model Catalog: 09.223.052S (Lot serial: all lots); Model Catalog: 09.223.050S (Lot serial: all lots); Model Catalog: 09.223.048S (Lot serial: all lots); Model Catalog: 09.223.046S (Lot serial: all lots); Model Catalog: 09.223.044S (Lot serial: all lots); Model Catalog: 09.223.042S (Lot serial: all lots); Model Catalog: 09.223.040S (Lot serial: all lots); Model Catalog: 09.223.038S (Lot serial: all lots); Mod
  • Descripción del producto
    COCR DYNAMIC LOCKING SCREW SELF TAPPING
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC