Z-1718-2015 Class II Terminated

Recalled by Advanced Back Technologies, Inc. — Hauppauge, NY

Recall Details

Product Type
Devices
Report Date
June 17, 2015
Initiation Date
May 13, 2015
Termination Date
May 23, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18 units

Product Description

Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)

Reason for Recall

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

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.

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