Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
FDA Recall Z-1718-2015 · Posted 2015-06-05
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Recalling FirmAdvanced Back Technologies, Inc.
Recall StatusTerminated
Product CodeITH
Date Initiated2015-05-13
Date Terminated2018-05-23
Product Quantity18 units
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
Firm 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 treat patients with a maximum weight exceeding 300 lbs until the firm is able to make an amendment to their 510(k). Customers with questions should call 631-231-0076.
Root Cause
Error in labeling
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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