Events

Recall of Device Recall Extentrac Elite User Manual DCN: 14001

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Back Technologies, 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
    71058
  • Event Risk Class
    Class 2
  • Event Number
    Z-1718-2015
  • Event Initiated Date
    2015-05-13
  • Event Date Posted
    2015-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136934
  • 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
    Equipment, traction, powered - Product Code ITH
  • Reason
    Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs.
  • Action
    Advanced Back Technologies, Inc. sent an Urgent Medical Device Brocure & User Manual Recall letter dated May 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed the discard the DCN's identified as DCN 13-001, DCN 09-001, DCN 14-001 and replace with the newly issued DCN 15-001, DCN 15-002. The new DCN's would be provided to customers in pdf format via email for issuance. Customers were asked to contact their customers who purchased the affected product and inform them that they should not treat patients with a maximum weight exceeding 300 lbs until the firm is able to make an amendment to their 510(k). Customers with questions should call 631-231-0076.

Device

Device Recall Extentrac Elite User Manual DCN: 14001
  • Model / Serial
    Serial Numbers: 005, 006, 011, 017, 019, 0701101, 07071003, 07071004, 08031005, 08081006, 08091007, 09061009, 09091010, 09101011, 09101012, 10021014, 10031015, 10091017, 10121019, 11051020, 11061021, 11071022, 11091023, 12011026, 12081028, 13021028, 12091029, 12091030, 12121032, 13011033, 13101034, 13071037, 13031035, 14011038, 14041036 and 14061038
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
  • Product Description
    Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
  • Manufacturer
    Advanced Back Technologies, Inc.

Manufacturer

Advanced Back Technologies, Inc.
  • Manufacturer Address
    Advanced Back Technologies, Inc., 89 Cabot Ct Ste F, Hauppauge NY 11788-3719
  • Manufacturer Parent Company (2017)
    Advanced Back Technologies Inc
  • Source
    USFDA