• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA slaps Class I status on Mizuho OSI surgical tables

FDA slaps Class I status on Mizuho OSI surgical tables

November 11, 2011 By MassDevice staff

Mizuho OSI

The FDA slapped Class I status on the recall of Mizuho Orthopedic Systems Inc.’s modular table system after reports surfaced of patients falling to the floor during procedures.

The tables are designed to allow physicians to position patients for a variety of orthopedic trauma, thoracic, and spinal surgery procedures, according to the federal watchdog agency.

"The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient falling to the floor," according to the FDA. "Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery. Both of the above may result in serious injury or death."

Sign up to get our free newsletters delivered right to your inbox

Mizuho issued a field advisory notice July 29 to tell health care providers how to safely set up and operate the tables, including a verification count of the T-pins.

"While FDA agrees that the factors identified by the firm may have contributed to some reported failures, FDA is concerned that the firm has not identified all factors contributing to these events," according to the agency. "Questions should be directed to Mizuho on their toll-free hotline at 1-800-777-4674, Monday through Friday from 9:00 am to 5 pm, Pacific Time."

Filed Under: Food & Drug Administration (FDA), News Well, Recalls Tagged With: Mizuho OSI

More recent news

  • Imperative Care has positive stroke treatment study results
  • Medtronic enrolls first patient in study for Onyx liquid embolic system
  • Intuitive demonstrates remote telesurgery capabilities with da Vinci 5
  • BD issues voluntary recall on certain Alaris infusion pump modules
  • CVRx announces Medicare win for Barostim therapy

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy