Class II — Potential Health Hazard

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

Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm Recalled by X Spine Systems Inc Due to The Continuous Radius Rod should measure 50mm in...

Date: April 7, 2015
Company: X Spine Systems 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 X Spine Systems Inc directly.

Affected Products

Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400

Quantity: 75 units

Why Was This Recalled?

The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.

Where Was This Sold?

This product was distributed to 11 states: FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA, TX

Affected (11 states)Not affected

About X Spine Systems Inc

X Spine Systems Inc has 7 total recalls tracked by RecallDetector.

Related Recalls

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