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))
Reported: February 26, 2025 Initiated: January 3, 2025 #Z-1177-2025
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.
Details
- Recalling Firm
- XTANT Medical Holdings, Inc
- Units Affected
- 14 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
- Location
- Belgrade, MT
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.
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