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

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

Code information: X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963

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