Z-1718-2015 Class II Terminated
FDA device recall Z-1718-2015 was initiated by Advanced Back Technologies, Inc. on May 13, 2015 and is designated Class II. 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 The recall status is terminated (terminated May 23, 2018). Affected quantity: 18 units.
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