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XTANT Medical recalls X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Recalled February 9, 2022 · FDA recall Z-0533-2022 · XTANT Medical
Hazard
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert. · FDA Class II
Units
24 devices
Sold at
U.S.: CA, MI, NV, and TX O.U.S.: Portugal
Description
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Product
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Manufacturer(s)
XTANT Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →