Recall Z-1717-2015— Advanced Back Technologies, Inc.

Name: FDA recall Z-1717-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-13

Class II · Terminated

Class II FDA medical device recall by Advanced Back Technologies, Inc., initiated 2015-05-13, terminated 2018-05-23. It names one FDA 510(k) clearance: K031996. Product: Extentrac Elite product brochure DCN: 13-001, 09-001 (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.

Recalling firm: Advanced Back Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-05-13
Terminated: 2018-05-23
Firm location: Hauppauge, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K031996 — EXTENTRAC ELITEAdvanced Back Technologies·cleared 2004-07-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Extentrac Elite product brochure DCN: 13-001, 09-001 (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

Data sourced from openFDA. This site is unofficial and independent of the FDA.