Home / Recalls / Atlas Spine, Inc. / Z-1616-2016

Z-1616-2016 Class II Terminated

Recalled by Atlas Spine, Inc. — Jupiter, FL

Recall Details

Product Type: Devices
Report Date: May 18, 2016
Initiation Date: July 26, 2013
Termination Date: July 26, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16

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.

Distribution Pattern

Nationwide Distribution to FL, MO, and WV.

Code Information

Lots #: 8887, 000073, 000135, 00434, and 02518.