CLASS II ONGOING Device recall · Reported 26 Feb 2025 · FDA Enforcement Report

Irix-A Integrated Lumbar Fusion System recalled

Xtant Medical Holdings is recalling Irix-A Integrated Lumbar Fusion System, distributed nationwide in the US. The recall was initiated on 3 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028

Quantity recalled14 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1177-2025
FDA event ID: 96179
Recalling firm: Xtant Medical Holdings, Belgrade, MT
Classification: Class II
Status: Ongoing
Recall initiated: 3 Jan 2025
FDA classified: 19 Feb 2025
Reported: 26 Feb 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Jan 2025	Recall initiated by company
19 Feb 2025	Classified by FDA	+47 days
26 Feb 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

Product as listed by the FDA

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))

Where it was distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.

Nationwide Arizona California Colorado Louisiana Ohio Texas West Virginia

Questions about this recall

Why was it recalled?

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

Which lots are affected?

Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028

Where was it sold?

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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