Z-1718-2015Class II

Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)

Name: Z-1718-2015 Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
Creator: Advanced Back Technologies, Inc.
Published: 2015-05-13
License: https://open.fda.gov/license/

Advanced Back Technologies / initiated 2015-05-13 / Terminated / root cause: labeling and UDI

FDA source

Advanced Back Technologies, Inc. began a recall of Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction) on 2015-05-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1718-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-13
Posted: 2015-06-05
Terminated: 2018-05-23
Recalling firm: Advanced Back Technologies
Product: Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
Product code: ITH Equipment, Traction, Powered
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 18 units
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1718-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1717-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-05
Z-1718-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-05

Product code ITH

K031996Class IIExtentrac EliteAdvanced Back Technologies / cleared 2004-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)