Events

Rappel de Device Recall Modular Table 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 Mizuho Orthopedic Systems 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
    59536
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0073-2012
  • Date de mise en oeuvre de l'événement
    2011-07-29
  • Date de publication de l'événement
    2011-10-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103036
  • 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
    Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
  • Cause
    Reports of injury related incidents while using the mizuho osi modular table system.
  • Action
    Mizuho Orthopedic Systems Inc sent a "Field Advisory Notice (Recall)" letters dated July 29, 2011 to all customers using the Modular Table System via Federal Express. The Field Advisory Notice reference the devices involved and explain that there is no need to return any product or to discontinue the use. The letter provides WARNINGS and RECOMMENDATIONS for all users to consider when using the devices and request that the response form be completed as instructed in the advisory communication. The letters also recommend that awareness, training, inspection prior to use, and proper maintenance be established and practiced. The letter recommend that the Field Advisory Notices be posted in prominent areas and communicated to all staff and potential users of this device. Additional support and training can be obtained by contacting Mizuho OSI's Customer Resource Group at 1-800-777-4674. For further questions concerning this notification, contact the Director of Customer Resource Group for assistance (1-800-777-4674, outside the USA 00+1-510-476-8199). Revised letters were approved by CDRH and sent out in January 2012.

Device

Device Recall Modular Table System
  • Modèle / numéro de série
    Model numbers 5803, 5855, 5890, 5891, 5892, 5895, 5927, 5840-726, 5840-831, 5943, 5843A, 5996, 5996I and 6977.; all codes Mizuho OSI, 30031 Ahern Ave., Union City, CA 94587
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide USA
  • Description du dispositif
    Mizuho OSI Modular Table System; || Product Usage: For use in orthopaedic surgery to provide support to a patient.
  • Manufacturer
    Mizuho Orthopedic Systems Inc

Manufacturer

Mizuho Orthopedic Systems Inc
  • Adresse du fabricant
    Mizuho Orthopedic Systems Inc, 30031 Ahern Ave, Union City CA 94587
  • Société-mère du fabricant (2017)
    Mizuho Co. Ltd.
  • Source
    USFDA