FDA-Device2022-02-09Class II
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
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.
Sold states
U.S.: CA, MI, NV, and TX O.U.S.: Portugal
Affected count
24 devices
Manufactured in
664 Cruiser Ln, N/A, Belgrade, MT, United States
Products
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0533-2022Don't want to check this manually?
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