Class 2 Device Recall Axle Interspinous Fusion System

• Date Initiated by Firm: December 29, 2021
• Create Date: January 28, 2022
• Recall Status: Terminated on June 17, 2024
• Recall Number: Z-0533-2022
• Recall Event ID: 89367
• 510(K)Number: K130438
• Product Classification: Spinous process plate - Product Code PEK
• Product: X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
• Code Information: X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963
• Recalling Firm/ Manufacturer: XTANT Medical; 664 Cruiser Ln; Belgrade MT 59714-9719
• For Additional Information Contact: Michele Dolan; 406-813-4145
• Manufacturer 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 Determined 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: mdolan@xtantmedical.com Fax: 1-406-388-3380 3. Return Affected Product Contact Michele Dolan at mdolan@xtantmedical.com, 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PEK