BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1718-2015 · Initiated May 13, 2015

    Recall

    Recall Number
    Z-1718-2015
    Event Number
    71058
    Firm
    Advanced Back Technologies, Inc.
    FEI Number
    3004755153
    Product Code
    ITH
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 13, 2015
    Posted
    June 5, 2015
    Terminated
    May 23, 2018
    Address
    89 Cabot Ct, Ste F, Hauppauge, NY, 11788-3719

    Description

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

    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

    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.

    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.

    Quantity

    18 units