Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Atlas Spine Torque Limiting Handle 6N-m Recalled by Atlas Spine, Inc. Due to The device was not appropriately set to mitigate...

Date: July 26, 2013
Company: Atlas Spine, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Atlas Spine, Inc. directly.

Affected Products

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

Quantity: 16

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Atlas Spine, Inc.

Atlas Spine, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report