Z-1177-2025Class II

Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC...

Name: Z-1177-2025 Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC...
Creator: XTANT Medical Holdings, Inc
Published: 2025-01-03
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2025-01-03 / Open, Classified / root cause: labeling and UDI

FDA source

XTANT Medical Holdings, Inc began a recall of 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... on 2025-01-03. FDA classified it as Class II and gives the reason as "Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1177-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-03
Posted: 2025-02-19
Recalling firm: Xtant Medical Holdings, Inc.
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))
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Root cause tag: labeling and UDI
FDA root 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: [email protected] Fax: 1-406-388-3380 4. Return Affected Product Contact Michele Dolan at [email protected], 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.
Product codes and lots: Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1177-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1177-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19

Product code OVD

K171567Class IIIRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. / cleared 2017-08-28

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)