Advanced Back Technologies, Inc. recalls Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
- Recall date
- May 13, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1717-2015
- FDA classification
- Class II
- Brand / firm
- Advanced Back Technologies, Inc.
- Sold / distributed
- Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
Why it was recalled
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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
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