Recall Z-0533-2022— XTANT Medical

Name: FDA recall Z-0533-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-29

Class II · Terminated

Class II FDA medical device recall by XTANT Medical, initiated 2021-12-29, terminated 2024-06-17. It names one FDA 510(k) clearance: K130438. Product: 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..

Recalling firm: XTANT Medical
Classification: Class II
Status: Terminated
Initiated: 2021-12-29
Terminated: 2024-06-17
Firm location: Belgrade, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K130438 — AXLE INTERSPINOUS FUSION SYSTEMX-Spine Systems, Inc.·cleared 2013-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.