Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 26, 2025
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))
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Xtant Medical Holdings, Inc recalled Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X … - a moderate-severity action.
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X … was recalled by Xtant Medical Holdings, Inc in February 26, 2025. Reason: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expirati…. Check the official notice for the remedy. Verify recall #Z-1177-2025 with the FDA Devices before acting.
The recall
Xtant Medical Holdings, Inc issued this moderate-severity FDA Devices recall-Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expirati….
- Moderate
- severity level
- 14 units
- affected scope
- Class II
- classification
- February 26, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1177-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1177-2025) was formally reported on February 26, 2025, with the manufacturer initiating the action on January 3, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Xtant Medical Holdings, Inc is listed as the recalling firm, operating out of Belgrade, MT. Federal records list the affected scope as 14 units.
The documented reason for this recall is: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
14 units
Related Recalls
6
3 from same agency
Product description
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))
Reason for recall
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1177-2025 |
| Date reported | February 26, 2025 |
| Date initiated | January 3, 2025 |
| Recalling firm | Xtant Medical Holdings, Inc |
| Firm location | Belgrade, MT |
| Affected scope | 14 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1177-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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)). Recalled by Xtant Medical Holdings, Inc. Units affected: 14 units.
Why was this product recalled? ▼
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2025. Severity: Moderate. Recall number: Z-1177-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1177-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 26, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.