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FDADecember 29, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

xtant medicalxtant

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. — Recall Details · AllClear