Recall Z-2556-2025 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Omnia Medical
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
| Date | Sep 11, 2025 (initiated Jul 15, 2024) |
| Status | Open, Classified |
| Reason | Failure of fusion system instruments in the field. |
| Root cause | Device Design |
| Action | Consignees were called on or around 8/1/2024 to notify them of this recall of instruments. Affected instruments were to be sent back to Omnia Medical and replaced with instruments that underwent rework in the form of design changes aimed at increasing their durability. |
| Quantity | 15 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203207 | Omnia Medical TiBrid-SA Omnia Medical, LLC, Dec 23, 2020 |