Events

Rappel de DePuy Synthes Craniomaxillofacial Distraction System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Synthes, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68071
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2148-2014
  • Date de mise en oeuvre de l'événement
    2014-04-16
  • Date de publication de l'événement
    2014-08-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126898
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    External mandibular fixator and/or distractor - Product Code MQN
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Adresse du fabricant
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA