Events

Recall of Device Recall Point Setter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mitaka USA, 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
    52454
  • Event Risk Class
    Class 2
  • Event Number
    Z-1539-2012
  • Event Initiated Date
    2009-02-27
  • Event Date Posted
    2012-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83534
  • 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
    Endoscope, neurological - Product Code GWG
  • Reason
    Use of a potentially weaker spring in the device than required to meet specifications to hold the point setter arm in place during surgery.
  • Action
    Mitaka USA sent a letter dated to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included instructions for returning the product. Contact the Customer Support Department at 800-421-0837, ext. 7577 for questions regarding this notice.

Device

Device Recall Point Setter
  • Model / Serial
    Inddivdual Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AZ, FL, CA, SC, OH, WA, TX, VA, MI, MO, GA, and NC and the country of Canada.
  • Product Description
    Mitaka Point Setter, holding system for surgical instruments. || Holding surgical instruments during operating procedures.
  • Manufacturer
    Mitaka USA, Inc.

Manufacturer

Mitaka USA, Inc.
  • Manufacturer Address
    Mitaka USA, Inc., 2337 Lucky John Dr, Park City UT 84060-6914
  • Manufacturer Parent Company (2017)
    Mitaka Usa Inc.
  • Source
    USFDA