Class II — Potential Health Hazard

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

OneLIF Torque Limiting Adapter Recalled by Novapproach Spine LLC Due to The torque limiting adapter may not stay locked...

Date: October 12, 2022
Company: Novapproach Spine LLC
Status: Completed
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 Novapproach Spine LLC directly.

Affected Products

OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.

Quantity: 6 devices

Why Was This Recalled?

The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Novapproach Spine LLC

Novapproach Spine LLC has 1 total recall tracked by RecallDetector.

Related Recalls

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