Recall Z-1718-2015 ยท ITH Equipment, Traction, Powered
Advanced Back Technologies, Inc.
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
| Date | Jun 5, 2015 (initiated May 13, 2015) |
| Status | Terminated |
| 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 |
| Root cause | Error in labeling |
| Action | Advanced Back Technologies, Inc. sent an Urgent Medical Device Brocure & User Manual Recall letter dated May 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed the discard the DCN's identified as DCN 13-001, DCN 09-001, DCN 14-001 and replace with the newly issued DCN 15-001, DCN 15-002. The new DCN's would be provided to customers in pdf format via email for issuance. Customers were asked to contact their customers who purchased the affected product and inform them that they should not t |
| Quantity | 18 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031996 | EXTENTRAC ELITE Advanced Back Technologies, Jul 23, 2004 |