Alphatec Spine, Inc. recalls Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended…

Recall date

May 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2249-2017

FDA classification

Class II

Brand / firm

Alphatec Spine, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of (TX, AL, UT, FL, IA, SD, NV, OH, CA, MN, CO, AZ, OK, MI, VA, KY, and Puerto Rico) and country of Japan

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).