Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
X060-0270 Recalled by XTANT Medical Due to The proximal opening of the inserts exhibit an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact XTANT Medical directly.
Affected Products
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Quantity: 24 devices
Why Was This 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.
Where Was This Sold?
This product was distributed to 4 states: CA, MI, NV, TX
About XTANT Medical
XTANT Medical has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report