X Spine Systems Inc recalls Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisbu…

Recall date

April 7, 2015

Source

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

Recall number

Z-1823-2015

FDA classification

Class II

Brand / firm

X Spine Systems Inc

Sold / distributed

Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.

Why it was recalled

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

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

What was recalled

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