Agency classClass IIOur severity:Moderate FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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)
Manufacturer: Advanced Back Technologies, Inc.
Category: Medical Device — Decompression Table
Hazard: mis-labeling
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 →

Moderate
Advanced Back Technologies Recalls Extentrac Elite User Manual
FDA (Devices) · 2015-06-17

Same hazard · mis labeling