X Spine Systems Inc recalls Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pe…

Recall date

March 11, 2015

Source

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

Recall number

Z-1512-2015

FDA classification

Class II

Brand / firm

X Spine Systems Inc

Sold / distributed

US Distribution to states of: KS, NV & TX.

Why it was recalled

One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.

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

What was recalled

Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.