Class II — Potential Health Hazard

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

ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw Recalled by Orthofix, Inc Due to Mislabeling

Date: May 18, 2015
Company: Orthofix, 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 Orthofix, Inc directly.

Affected Products

ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse

Quantity: 45 units

Why Was This Recalled?

The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.

Where Was This Sold?

This product was distributed to 9 states: CA, CO, FL, MD, MI, NY, OK, PA, SC

Affected (9 states)Not affected

About Orthofix, Inc

Orthofix, Inc has 30 total recalls tracked by RecallDetector.

Related Recalls

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