Advanced Back Technologies Recalls Extentrac Elite User Manual
Advanced Back Technologies is recalling 18 Extentrac Elite User Manuals because they incorrectly state the device is for patients up to 350 lbs, while the device is only approved for 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. The hazard is a labeling error regarding weight limits, which is a minor labeling error or low-risk contamination issue without reported injuries, fitting the Moderate severity criteria.
Plain-English summary
Advanced Back Technologies, Inc. is recalling 18 units of the Extentrac Elite User Manual (DCN: 14-001). The manual is associated with the Extentrac Elite powered decompression table, which is used for traction.
The recall is due to a labeling error in the user manual. The manual markets the device for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs. This discrepancy could lead to the device being used with patients who exceed the approved weight limit.
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. Specific serial numbers for the affected units are listed in the recall notice. Consumers and healthcare providers should stop using the affected manuals and contact Advanced Back Technologies for further instructions.
The recalled product
- Product
- Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
- Manufacturer
- Advanced Back Technologies, Inc.
- Hazard
- Affected units
- 18
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
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 →Related recalls
Same manufacturer · Advanced Back Technologies, Inc.
See all →- ModerateExtentrac Elite Powered Decompression Table Recalled for Weight Limit Mislabeling
FDA (Devices) · 2015-06-17
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