Events

Retiro De Equipo (Recall) de Trochar Scalpel Instrument (Surgical Punch)

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
    Recall
  • ID del evento
    63396
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0207-2013
  • Fecha de inicio del evento
    2012-09-13
  • Fecha de publicación del evento
    2012-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113679
  • 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
    Mixture, hematology quality control - Product Code HSB
  • Causa
    A complaint received from sales representative that a replenishment instrument was too short. upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
  • Acción
    OrthoPediatrics Corp sent an Urgent Recall e-mail dated September 14, 2012, to all affected customers. The e-mail identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all identified devices from the affected lot numbers immediately. Customers were also asked to complete the Mandatory Reply Form. Customers with questions should call 574-268-6379.

Device

Trochar Scalpel Instrument (Surgical Punch)
  • Modelo / Serial
    Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
  • Descripción del producto
    Trochar Scalpel Instrument (Surgical Punch) || OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
  • Manufacturer
    OrthoPediatrics Corp

Manufacturer

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