Events

Recall of Device Recall IntraOp

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
    38307
  • Event Risk Class
    Class 2
  • Event Number
    Z-0243-2008
  • Event Initiated Date
    2007-02-28
  • Event Date Posted
    2007-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53382
  • 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
    Operating room table - Product Code LHN
  • Reason
    Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.
  • Action
    The firm issued a Product Correction Notification letter by mail on 02/28/2007 and follow up with phone calls. The letter notified users that a required no-cost upgrade of the removal and replacement of a microprocessor that controls the logic for the floor locking mechanism will be conducted by the recalling firm.

Device

Device Recall IntraOp
  • Model / Serial
    Serial Numbers: 12-15, 17, 19, 21-57, 59-61, 64-67, 70, 71, 73-83, 85-93, 95, 97, 99-134 and 136-141
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA product was distributed to 16 wholesale dealers, 212 medical facilities, 14 distributors throughout the US in the following states: AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, VA, WA, WI, WV and WY and to the following countries Taiwan, Australia, German, Japan, Canada, Saudi Arabia, and The UK.
  • Product Description
    OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included)
  • Manufacturer
    Mizuho Orthopedic Systems Inc

Manufacturer

Mizuho Orthopedic Systems Inc
  • Manufacturer Address
    Mizuho Orthopedic Systems Inc, 30031 Ahern Ave, Union City CA 94587-1234
  • Source
    USFDA