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Advanced Back Technologies, Inc. recalls Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
Recalled June 17, 2015 · FDA recall Z-1717-2015 · Advanced Back Technologies
Hazard
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 · FDA Class II
Units
36 units
Sold at
Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
Description
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
Product
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
Manufacturer(s)
Advanced Back Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →