Class 2 Device Recall IrixA Lumbar Integrated Fusion System

• Date Initiated by Firm: January 03, 2025
• Date Posted: February 19, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1177-2025
• Recall Event ID: 96179
• 510(K)Number: K171567
• Product Classification: Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
• Product: Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8, 19mm, PC, (STERILE))
• Code Information: Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028
• Recalling Firm/ Manufacturer: XTANT Medical Holdings, Inc; 664 Cruiser Ln; Belgrade MT 59714-9719
• For Additional Information Contact: Michele Dolan; 937-847-8400
• Manufacturer Reason for Recall: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
• FDA Determined Cause: Labeling Change Control
• Action: An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers on 1/3/25. Specific actions to be taken by the Customer/User: Xtant is communicating this recall to all customers for which the affected device lot was distributed to. Our records indicate that product(s) affected by this recall were shipped to you. We request that you do the following: 1. Immediately examine your inventory and quarantine any affected products subject to this recall. See enclosed illustration for ease in identifying affected devices (see Attachment 2). 2. Please notify your staff of this Medical Device Recall and provide this notification to any customers for which the recalled product was further distributed. 3. Please complete the enclosed Acknowledgement Form (Attachment 1), even if you have no remaining devices in your inventory, and return the completed Acknowledgment Form to the attention of Michele Dolan via: Mail: Xtant Medical Medical Device Recall 664 Cruiser Lane Belgrade, MT 59714 Email: mdolan@xtantmedical.com Fax: 1-406-388-3380 4. Return Affected Product Contact Michele Dolan at mdolan@xtantmedical.com, or 1-406-599-3667, 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. 5. 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: Irix-A Integrated Lumbar Fusion System RA# 25-xxxx Xtant Medical 732 Cruiser Lane Belgrade, MT 59714 If you have any questions, please contact Rebecca Lennemann, Vice President of QARA, 1-406-924-5878, from 8a.m. to 5 p.m. (Mountain Time).
• Quantity in Commerce: 14 units
• Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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