Z-0533-2022Class II

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

Name: Z-0533-2022 X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System
Creator: XTANT Medical
Published: 2021-12-29
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2021-12-29 / Terminated

FDA source

XTANT Medical began a recall of X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System on 2021-12-29. FDA classified it as Class II and gives the reason as "The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0533-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-29
Posted: 2022-01-28
Terminated: 2024-06-17
Recalling firm: Xtant Medical Holdings, Inc.
Product: X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Product code: PEK Spinous Process Plate
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.
FDA root cause: Under Investigation by firm
Action: On 12/30/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx Priority Overnight (Direct Signature Required) to its distributes to notify their customer that a specific lot of their interspinous fusion systems were manufactured out of tolerance resulting in the distal end of the crossbar not properly engaging with the inserts. Customer are instructed to: 1. Immediately examine their inventory and quarantine any affected products subject to this recall. 2. Complete the enclosed Acknowledgement Form, even if customers have no remaining devices in their inventory, and return the completed Acknowledgment Form to the attention of Michele Dolan via: Mail: Xtant Medical Axle Interspinous Fusion System Recall 664 Cruiser Lane Belgrade, MT 59714 Email: [email protected] Fax: 1-406-388-3380 3. Return Affected Product Contact Michele Dolan at [email protected], or 1-406-388-0480 ext. 1127, between 8 a.m. and 5 p.m. (Mountain Time) to obtain instructions for returning affected product, and to obtain replacement devices, as applicable, which will be provided at no cost to you. 4. Package the affected products to be returned. Xtant will provide a shipping container (if needed) with a return shipping label. Securely package the affected product(s). Send the container at your earliest opportunity to: ATTN: Axle Interspinous Fusion Recall RA# 21-xxxx Xtant Medical 732 Cruiser Lane Belgrade, MT 59714 5. To Inform all their staff members of this recall and if affected products have been further distributed to contact all customers. For any questions contact the Director of Regulatory Affairs/Quality Assurance at 1-406-388-0480 ext. 1125 from 8 a.m. to 5 p.m. (Mountain Time).
Quantity in commerce: 24 devices
Distribution: U.S.: CA, MI, NV, and TX O.U.S.: Portugal
Product codes and lots: X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0533-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0533-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28

Product code PEK

K130438Class IIAxle Interspinous Fusion SystemX-Spine Systems, Inc. / cleared 2013-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)