Events

Recall of Device Recall Foot Lok Cushion

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Med Tec 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
    51317
  • Event Risk Class
    Class 3
  • Event Number
    Z-1721-2009
  • Event Initiated Date
    2009-03-06
  • Event Date Posted
    2009-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79849
  • 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, radiographic, stationary top - Product Code IXQ
  • Reason
    The silkscreened indexing scale was reversed.
  • Action
    Med Tec inc. (CIVCO Medical Solutions, Radiation Oncology) issued a "Recall Notification" notice dated March 6, 2009 via certified mail explaining the reason for recall and providing the customer a choice of returning the product for replacement or not take any action. A response form was enclosed to be returned via FAX to indicate the number of units in their possession and whether or not they are being returned. Telephone calls were initiated April 20, 2009 to nonresponders or for any consignee whose letter was returned as undeliverable. Foreign customers were notified by e-mail or phone beginning March 16, 2009. For further information, contact CIVCO Medical Solutions, Radiation Oncology at 1-800-842-8688.

Device

Device Recall Foot Lok Cushion
  • Model / Serial
    Lot NNumbers: M055260, M042340, M024020, M022010 and M006980
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Including the United States, Czech Republic, Colombia, Thailand, Morocco, Brazil, the United Kingdom, India, Costa Rica, The Netherlands, Russia, Spain, Israel, Taiwan, Mexico, Turkey, Korea, Australia, Malaysia, Italy and Japan.
  • Product Description
    Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.
  • Manufacturer
    Med Tec Inc

Manufacturer

Med Tec Inc
  • Manufacturer Address
    Med Tec Inc, 1401 8th St, PO Box 320, Orange City IA 51041-0320
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA