Events

Retiro De Equipo (Recall) de DePuy Synthes Craniomaxillofacial Distraction 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 Synthes, 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
    68071
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2148-2014
  • Fecha de inicio del evento
    2014-04-16
  • Fecha de publicación del evento
    2014-08-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126898
  • 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
    External mandibular fixator and/or distractor - Product Code MQN
  • Causa
    Depuy synthes is initiating a recall of certain lots of the craniomaxillofacial distraction system (ab distractor bodies and bc distractor bodies) because they may reverse post-operatively.
  • Acción
    The firm, DePuy Synthes, sent "Urgent Notice: Medical Device Recall" letters dated April 16, 2014 to affected customers. The letter identified the affected product, reason for recall, potential patient impact, mitigation steps for patients with distractors currently implanted and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from stock, complete verification section of the letter and return the affected product. For questions call 610-719-5450 or contact your DePuy Synthes Sales consultant.

Device

DePuy Synthes Craniomaxillofacial Distraction System
  • Modelo / Serial
    Part nos. 04.315.003, 04.315.004, 04.315.005, 04.315.006 04.315.023 04.315.024 04.315.025 04.315.026 04.315.027 04.315.028 04.315.053 04.315.054 04.315.055 04.315.056 04.315.063 04.315.064 04.315.065 04.315.066 04.315.067 04.315.068, with lot nos.: 6245205, 7129328, IS10400 6246203, 6582199, 6794535, 6814674, 6877737, 6921359, 6981567, 7008430, 7081952, 7129329, 7460419, 7556148  6246984, 6342006, 6964974, 7129330, 7460420, 6246983, 7389334, 7422735, 7515818  6245460, 6342005, 6454138, 6495399, 6651393, 6816023, 6898959, 6921360, 7306561, 7515824 6307904, 6365443, 6410544, 6438375, 6625839, 6651392, 6984928, 7241620, 7351855, 7390470, 7408179, 7458272, 7458273, 7458274, IS10394 6450702, 6454139, 6553925, 6625840, 6883404, 6921586, 7031344, 7185897, 7389329, 7408181, 7422706, 7422707, 7422708, 7458299, 7515832, IS10385 6393118, 6393119, 6410545, 6454140, 6512859, 6625841, 6651391, 6984925, 7185895, 7408182, 7422703, 7422704, 7422705, 7515829, 7515830 6393120, 7408180, 7515833  7122918, 7389333, 7422700, 7545381, IS10388 6252759, 7129331, 7155891, 7418771, 7448753  6245463, 6438376, 6981568, 6983876,7063885, 7129332,7309797, 7418772, 7418848, 7448754 6251769, 7081953, 7310030, 7365542, 7418849, 7448752, 7448758, 7556149 6245458, 6342007, 7129333, 7556150, IS10399 6245462, 6342003, 6824546, 6824551, 6883290, 6883301, 7082907, 7266972, 7476792, 7476810, 7657623 6280719, 6342004, 6394297, 6651390, 6737168, 6767617, 6824547, 6824550, 6883304, 6883305, 6961025, 6984927, 7041138, 7056051, 7111867, 7185893, 7266967, 7351857, 7351858, 7351859, 7351861, 7422701, 7545379, 7657820, IS10395, 6651389, 6702172, 6883306, 6883307, 6942444, 6984926, 7111868, 7185892, 7306562, 7306563, 7306564, 7499078, 7515834, 7657629, IS10389 6651388, 6741835, 6824553, 6883309, 6913921, 6942445, 6961024, 7082908, 7111869, 7122924, 7185888, 7515835, 7657633 6921585, 6942446, 7185887, 7306565, 7306566, 7408183, 7476791, 7567066, 7579433, 7657635, IS10390, IS10391, 6275129, 7082905, 7185890, 7266969, 7422697, 7609200, IS10386, IS10387
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Dirección del fabricante
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA