Recall Z-1177-2025 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
XTANT Medical Holdings, Inc
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))
| Date | Feb 19, 2025 (initiated Jan 3, 2025) |
| Status | Open, Classified |
| Reason | Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. |
| Root cause | Labeling Change Control |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers on 1/3/25. Specific actions to be taken by the Customer/User: Xtant is communicating this recall to all customers for which the affected device lot was distributed to. Our records indicate that product(s) affected by this recall were shipped to you. We request that you do the following: 1. Immediately examine your inventory and quarantine any affected products subject to this recall. See enclosed illustration for ease in identifying affected devices (see Attachment 2). 2. Please notify your staff of this Medical Device |
| Quantity | 14 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171567 | IRIX-A Lumbar Integrated Fusion System X-Spine Systems, Inc., Aug 28, 2017 |