Events

Rappel de Synthes Mandible External Fixator

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
    69533
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1009-2015
  • Date de mise en oeuvre de l'événement
    2014-10-17
  • Date de publication de l'événement
    2015-01-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130880
  • 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
    Under new testing protocols for mr environment safety and compatibility, metal devices are no longer designated mr safe. some components in the cmf mandible external fixator systems were labeled and/or etched with information indicating they are mr safe. they can no longer be labeled mr safe.
  • Action
    Urgent notices of medical device labeling updates, dated October 17, 2014 and October 24, 2014 were sent to end users and sales consultants, which described the product, problem, and action to be taken. These consignees were instructed to inspect inventory and remove out-dated labeling inserts and replace with updated labeling information.

Device

Synthes Mandible External Fixator
  • Modèle / numéro de série
    All lots of part nos.:  04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    The Synthes Mandible External Fixator; all lots of part nos.: || 04.305.003 || 04.305.004 || 04.305.005 || 04.305.010 || 04.305.011 || 04.305.012 || 03.305.006 || 04.305.100 || 04.305.101 || 04.305.102 || 04.305.103 || 04.305.128 || 04.305.130 || 04.305.134 || 04.305.138 || 04.305.140 || 04.305.142 || 03.305.105 || 03.305.500 || 03.305.500S || Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
  • 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