Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) an
Summary
The FDA issued a Class II for Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer As by XTANT Medical Holdings, Inc. Reason: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date..
Details
Source
Device Recall
External ID
Z-1177-2025
Action Date
2025-02-26
Status
Ongoing
Category
device
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))
Lot/Code Info: Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028
Quantity Affected: 14 units
Reason for Recall
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-03
Company
Belgrade, MT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
XTANT Medical Holdings, Inc has 6 FDA actions in our database, including 5 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (XTANT Medical Holdings, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does XTANT Medical Holdings, Inc have FDA actions?
XTANT Medical Holdings, Inc has 6 FDA actions in our database, including 5 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1177-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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