Events

Retiro De Equipo (Recall) de Grafton DBM Flex

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 Osteotech 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
    60263
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0415-2012
  • Fecha de inicio del evento
    2011-08-08
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104903
  • 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
    Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
  • Causa
    Aseptic conditions during the production of these products may have been compromised.
  • Acción
    Osteotech sent a recall letter dated August 8, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all units of the affected product. Customers were asked to contact Osteotech Customer Service at 732-578-6699 within two business days of receiving the letter to acknowledge receipt of the letter and to arrange for a return and exchange or credit for the product. For questions regarding this recall call 732-542-2800.

Device

Grafton DBM Flex
  • Modelo / Serial
    Catalog Number A42150 Lot #OTSCT08 2845 exp 4/30/14 Catalog Number A4215000000000 Lot #OTSCT08 2845 exp 4/30/14
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Grafton DBM Flex; Unit Size 5x5 cm; 1ea || Container: Foil Pouch with Tyvek pouch || Fracture repair, bridge bone gaps or fragments, use with strut grafts
  • Manufacturer
    Osteotech Inc

Manufacturer

Osteotech Inc
  • Dirección del fabricante
    Osteotech Inc, 51 James Way, Eatontown NJ 07724-2272
  • 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
    USFDA