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Recall Observatory FDA recall evidence

Device product

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

Z-1717-2015

May 13, 2015

Class II

Product summary

Firm
Advanced Back Technologies, Inc.
Event
Event 71058
Status
Terminated
Classification
Class II
Quantity
36 units
Official record key
device-enforcement:Z-1717-2015

Official wording

Reason: 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

Code information: Serial Numbers: 005, 006, 011, 017, 019, 0701101, 07071003, 07071004, 08031005, 08081006, 08091007, 09061009, 09091010, 09101011, 09101012, 10021014, 10031015, 10091017, 10121019, 11051020, 11061021, 11071022, 11091023, 12011026, 12081028, 13021028, 12091029, 12091030, 12121032, 13011033, 13101034, 13071037, 13031035, 14011038, 14041036 and 14061038

Distribution pattern: Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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

Field note

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