Events

Recall of Device Recall Coupler System II

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
    61275
  • Event Risk Class
    Class 2
  • Event Number
    Z-1203-2012
  • Event Initiated Date
    2012-02-27
  • Event Date Posted
    2012-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107701
  • 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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • Reason
    Mizuho determined that current labeling of the coupler ii system required revisions after investigation of a complaint.
  • Action
    Mizuhosi OSI sent an Urgent Medical Device Recall Communication letter dated February 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Mizuho OSI provided their customers of the affected product an updated Owner's manual. Customers were instructed to ensure they remove their existing Owner's Manual from use and repalce with the current Owner's Manual. If customers were unsure of the device's use, they should refer to the included Owner's Manual and ensure all users are properly trained, able to assess the device's status prior to and after each use. If customers were unsure of the status of their device, or of its use, they should call 1-800-777-4674 or outside of the USA 00+1=510-476-8199. Customers were asked to respond that the recall has been received, read, understood and communicated to those affected by this activity. A response should be sent via e-mail to couplerII@mizuhois.com. For any questions regarding this recall call 1-800-777-4674 or outside of the USA 00+1=510-476-8199. was sent out on February 27, 2012 to all affected sites. This was after the original was sent to CDRH for review on January 31, 2012, but approval of revisions was not received until 2/27/12.

Device

Device Recall Coupler System II
  • Model / Serial
    Model 5873
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Japan, South Korea, Lebanon, Malaysia, Netherlands, New Zealand, South Arabia, Singapore, Germany, South Africa, Spain, Sweden, UA. E., United Kingdom, and Australia.
  • Product Description
    Coupler System II || Mizuho Orthopedic Systems, Inc. || Union City, CA 94587 || The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield¿ clamp or the radiolucent or aluminum skull clamp referred to as the DORO¿ which is manufactured by pro med instruments Inc.
  • 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