Recall Z-1616-2016— Atlas Spine, Inc.

Name: FDA recall Z-1616-2016
Creator: U.S. Food and Drug Administration
Published: 2013-07-26

Class II · Terminated

Class II FDA medical device recall by Atlas Spine, Inc., initiated 2013-07-26, terminated 2019-07-26. It names 2 FDA 510(k) clearances: K091406, K063205. Product: Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position. Reason: The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space..

Recalling firm: Atlas Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-26
Terminated: 2019-07-26
Firm location: Jupiter, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K091406 — ATLAS SPINE SPACERAtlas Spine, LLC·cleared 2009-09-04
K063205 — ATLAS SPINE VERTEBRAL BODY REPLACEMENTAtlas Spine, LLC·cleared 2007-02-26

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

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

Reason for recall

The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

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