Events

Retiro De Equipo (Recall) de Device Recall OrthoPediatrics PediLoc Locking Plate 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 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
    65828
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1941-2013
  • Fecha de inicio del evento
    2013-07-24
  • Fecha de publicación del evento
    2013-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120334
  • 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 # 01-1050-002, 2.5mm drill bit, lot #91300335. only drill bits that are in their original packaging are being recalled. the description on the package of this drill bit has a wrong size in the description (3.2mm). the recall affects only packaged devices still in original packaging due to misbranding of the product. the drill bit itself has.
  • Acción
    On 7/24/13, OrthoPediatrics notified their consignees of this URGENT MEDICAL DEVICE RECALL via phone call. A follow-up email message was then sent with the recall notification, and then a hard copy of the notice was sent via certified letter. The notification addresses the affected product, recall issue, reply form instructions, and directs consignees to return affected product to OrthoPediatrics via a Fed-Ex return prepaid pouch. The firm directs consignees to forward the notification and reply form if the product was further distributed.

Device

Device Recall OrthoPediatrics PediLoc Locking Plate System
  • Modelo / Serial
    LOT 91300335 - Catalogue Number 01-1050-0002
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
  • Descripción del producto
    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
  • 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