Events

Recall of Device Recall Performa TM300 Traction System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sammons Preston Rolyan, An Ability One Company.

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
    31492
  • Event Risk Class
    Class 3
  • Event Number
    Z-1444-05
  • Event Initiated Date
    2005-07-13
  • Event Date Posted
    2005-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37983
  • 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
    Apparatus, Traction, Non-Powered - Product Code HST
  • Reason
    The traction device may malfunction, producing oscillation and a jerking motion.
  • Action
    Sammons Preston Roylan, the U.S. agent for Ito Co., Ltd. issued recall letters dated 7/13/05 to all of their customers who purchased the Performa TM-300 traction unit, informing them that the manufacturer, Ito Co., Ltd., is recalling the units because the units may exhibit oscillation during some traction modes. The accounts were requested to contact Tina Kreisher at 1-800-323-5547, ext. 1383 if their TM-300 unit has a serial number that falls in the range listed in the recall letter. Tina will arrange for the unit to be shipped to the manufacturer's authorized repair center for upgrading of the software to version 2.8, and for the shipment of a loaner unit while their unit is being upgraded.

Device

Device Recall Performa TM300 Traction System
  • Model / Serial
    Product No. A501-009, serial numbers 1000 through 1207
  • Product Classification
    Neurological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia
  • Product Description
    TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan
  • Manufacturer
    Sammons Preston Rolyan, An Ability One Company

Manufacturer

Sammons Preston Rolyan, An Ability One Company
  • Manufacturer Address
    Sammons Preston Rolyan, An Ability One Company, 4 Sammons Ct, Bolingbrook IL 60440-4995
  • Source
    USFDA