Events

Retiro De Equipo (Recall) de Device Recall FassierDuval Telescopic IM System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Pega Medical 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
    54620
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1494-2011
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2011-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88796
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    orthopedic manual instrument - Product Code HSB
  • Causa
    Possible breakage. structural weakness has been detected on the male driver 3.2mm and 4.0mm sizes. in certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component.
  • Acción
    On 01/29/2010, Pega Medical began contacting their consignees by e-mail and telephone. Pega Medical followed up with their consignees by sending out the replacement components along with the explanation letter. The subject on the letter is Notice for 3.2 mm and 4.0 mm Male Drivers of the Fassier-Duval IM Telescopic System. The consignees were informed that there could be a structural weakness in some of the Male Driver instruments. This problem has been detected on the 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component. Consignees can contact Pega Medical at 450-688-5144 x 242.

Device

Device Recall FassierDuval Telescopic IM System
  • Modelo / Serial
    Catalog number MDr132L (size 3.2 mm) with Lot Code 270730-01.   Catalog number MDr140L (size 4.0 mm) with Lot Code 270730-02.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Components were distributed to four hospitals in the US in the state of GA, OK, TN, and UT.
  • Descripción del producto
    Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation.
  • Manufacturer
    Pega Medical Inc.

Manufacturer

Pega Medical Inc.
  • Dirección del fabricante
    Pega Medical Inc., 1105 Autoroute Chomedy, Laval Canada
  • Empresa matriz del fabricante (2017)
    Pega Medical Inc.
  • Source
    USFDA