Events

Recall of Device Recall Mizuho Orthopedic Systems, Inc.

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

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
    63991
  • Event Risk Class
    Class 2
  • Event Number
    Z-0810-2013
  • Event Initiated Date
    2012-12-17
  • Event Date Posted
    2013-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115181
  • 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
    Possible instability of orthopedic table top. if the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. if this occurs, the orthopedic table spar may need to be replaced to ensure stability of the orthopedic table top.
  • Action
    Mizuho sent a Recall Notification letter dated December 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Orthopedic Table Spar will be replaced at no cost by Mizuho technicians. Customers were informed the potential failure and were advised inspection of tables prior to use. If tables are experiencing the described failure, contact Mizuho Resource Group at 1-800-777-4674, option 2. .

Device

Device Recall Mizuho Orthopedic Systems, Inc.
  • Model / Serial
    Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Distribution -- Worldwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Canada, Egypt, Finland, France, Germany, China, Israel, Italy, Japan, Netherlands, New Zealand, P.R. China, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Taiwan R.O.C., UAE and UK.
  • Product Description
    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
  • Manufacturer
    Mizuho OSI

Manufacturer

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