Product Safety Recalls

Product Recall Tracker

XTANT Medical Recall 89367

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

XTANT Medical Recall 89367 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0533-2022
Event ID89367
Event DescriptionX060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Product TypeDevices
DistributionU.S.: CA, MI, NV, and TX O.U.S.: Portugal
Quantity24 devices
Recall ReasonThe proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Device Classification20220209
Device Code InfoX060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963
Center Classification Date20220128
Recall Initiation Date20211229
Recalling FirmXTANT Medical
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.