FDAClass IIJune 17, 2015

Extentrac Elite product brochure DCN: 13-001 recall

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

Why was Extentrac Elite product brochure DCN: 13-001 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
Recalling firm
Advanced Back Technologies, Inc.
Quantity
36 units
Distribution
Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
Recall date
June 17, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls