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U.S. Department of Health and Human Services

Class 2 Device Recall Extentrac Elite User Manual DCN: 14001

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  Class 2 Device Recall Extentrac Elite User Manual DCN: 14001 see related information
Date Initiated by Firm May 13, 2015
Date Posted June 05, 2015
Recall Status1 Terminated 3 on May 23, 2018
Recall Number Z-1718-2015
Recall Event ID 71058
510(K)Number K031996  
Product Classification Equipment, traction, powered - Product Code ITH
Product Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
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
Recalling Firm/
Manufacturer		 Advanced Back Technologies, Inc.
89 Cabot Ct Ste F
Hauppauge NY 11788-3719
For Additional Information Contact
631-231-0076
Manufacturer 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
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITH and Original Applicant = ADVANCED BACK TECHNOLOGIES
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