XTANT Medical recalls X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.

Recall date

December 29, 2021

Source

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

Recall number

Z-0533-2022

FDA classification

Class II

Brand / firm

XTANT Medical

Sold / distributed

U.S.: CA, MI, NV, and TX O.U.S.: Portugal

Why it was recalled

The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.

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

What was recalled

X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.