Events

Recall of Device Recall Modular Table System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mizuho Orthopedic Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59536
  • Event Risk Class
    Class 1
  • Event Number
    Z-0073-2012
  • Event Initiated Date
    2011-07-29
  • Event Date Posted
    2011-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103036
  • Notes / Alerts
    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.
  • Extra notes in the data
    Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide USA
  • Product Description
    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
  • Manufacturer Address
    Mizuho Orthopedic Systems Inc, 30031 Ahern Ave, Union City CA 94587
  • Manufacturer Parent Company (2017)
    Mizuho Co. Ltd.
  • Source
    USFDA