Class II — Potential Health Hazard

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

Arsenal Spinal Fixation System Recalled by Alphatec Spine, Inc. Due to Alphatec Spine is recalling the Arsenal Spinal Fixation...

Date: May 5, 2017
Company: Alphatec 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 Alphatec Spine, Inc. directly.

Affected Products

Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).

Quantity: 16,959 units

Why Was This Recalled?

Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Alphatec Spine, Inc.

Alphatec Spine, Inc. has 45 total recalls tracked by RecallDetector.

Related Recalls

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