Irix-A Integrated Lumbar Fusion System recall
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number…
Why was Irix-A Integrated Lumbar Fusion System recalled?
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- 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…
- Recalling firm
- XTANT Medical Holdings, Inc
- Quantity
- 14 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
- Recall date
- February 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)