The Recall Desk
ModerateFDA (Devices)·Z-1717-2015·Announced 2015-06-17

Extentrac Elite Powered Decompression Table Recalled for Weight Limit Mislabeling

Advanced Back Technologies is recalling 36 Extentrac Elite powered decompression tables because the product brochure incorrectly states a 350-lb weight limit, while the device is only approved for patients up to 300 lbs.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error regarding weight limits rather than a direct contamination or structural defect, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.

Plain-English summary

Advanced Back Technologies, Inc. is recalling 36 units of the Extentrac Elite powered decompression table. The recall is due to a labeling error in the product brochure (DCN: 13-001, 09-001), which markets the device for use in patients weighing up to 350 lbs. However, the device was only approved for use in patients up to 300 lbs.

The affected units were distributed worldwide, including in the United States (California, Florida, New Jersey, Texas, Washington) and internationally in Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, and Australia. The recall covers specific serial numbers listed in the agency's records.

Consumers and healthcare providers should stop using the affected devices and contact Advanced Back Technologies, Inc. for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
Affected units
36

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial Numbers: 005
  • 006
  • 011
  • 017
  • 019
  • 0701101
  • 07071003
  • 07071004
  • 08031005
  • 08081006
  • 08091007
  • 09061009
  • 09091010
  • 09101011
  • 09101012
  • 10021014
  • 10031015
  • 10091017
  • 10121019
  • 11051020

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 2 recalled by Advanced Back Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Advanced Back Technologies, Inc.

See all →