Atlas Spine, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1616-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 26, 2013

Date Posted: May 18, 2016

Recall Number: Z-1616-2016

Event ID: 73657

Reason for Recall:

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

Status: Terminated

Product Quantity: 16

Code Information:

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

Distribution Pattern:

Nationwide Distribution to FL, MO, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated