X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
FDA Recall #Z-0533-2022 — Class II — December 29, 2021
Product Description
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Reason for Recall
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Recalling Firm
XTANT Medical — Belgrade, MT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
24 devices
Distribution
U.S.: CA, MI, NV, and TX O.U.S.: Portugal
Code Information
X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated