Events

Retiro De Equipo (Recall) de INFUSE BONE GRAFT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDTRONIC OF 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
    24947
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-06-13
  • 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
    Product associated with a voluntary recall being conducted by integra lifesciences corporation. specifically integra life sciences corporation has recalled certain lots of the absorbable collagen sponge (acs) which is a component of the infuser bone graft kit. integra lifesciences corporation announced the voluntary recall advising us as follows: "integra life sciences has identified through an internal quality assurance review of processes that we may have deviated from a production process during the manufacture of specific lots of product. accordingly we are recalling those specific lots. the product lots in question passed all product finished goods testing are sterile and were tested and accepted for endotoxin levels. however due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products. higher endotoxin levels may result in a fever in the immediate postoperative period. we are not aware of any reports of patient injuries or other adverse events in connection with these product lots. however if you have already implanted or used collagen sponge products affected by this recall we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol.".

Device

INFUSE BONE GRAFT
  • Modelo / Serial
    Model Catalog: 7510200 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 7510400 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 7510600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 7510800 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    INFUSE BONE GRAFT
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Dirección del fabricante
    BRAMPTON
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC