Retiro De Equipo (Recall) de Device Recall 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm

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 OrthoPediatrics Corp.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    Orthopediatrics has initiated a voluntary recall of part # 00-0903-2620, 3.5mm locking cortical screw, lot # 009sv because the device within the package may be incorrect. these packages incorrectly contain a 3.5mm non locking cortical screw # 00-1050-3524.
  • Acción
    Orthopediatrics Corporation has requested sales representatives and distributors who have been identified via shipping records as having the possibility of having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on January 8, 2014. The decision to Recall these devices was made and a formal written Recall Notice sent to the consignees via email on January 13, 2014. Notification will not be sent to hospitals at this time provided that all devices are retrieved or accounted for within 60 days of the initiation of recall. Hospitals will be notified on an as needed basis if OrthoPediatrics determines that all recalled devices have not been recovered or accounted for, and that contacting the hospitals involved will expedite the recall efforts. All discrepant devices subject to this voluntary Recall are planned to be returned from distribution to OrthoPediatrics Corp. in Warsaw, Indiana and maintained in quarantine. All remaining unshipped devices from these lots have been placed in quarantine at OrthoPediatrics Corp. All quarantined devices at OrthoPediatrics will be inspected and repackaged to correct the mislabeling per normal documented procedures. Objective evidence will be maintained of the rework of the devices. For questions regarding this recall call 574-268-6379.


  • Modelo / Serial
    Lot 009SV
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
  • Descripción del producto
    3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm || Part No. 00-0903-2620 || OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
  • Manufacturer


  • Dirección del fabricante
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • Empresa matriz del fabricante (2017)
  • Source