Device product
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Z-2557-2025
Product summary
- Firm
- Omnia Medical
- Event
- Event 97402
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-2557-2025
Official wording
Reason: Failure of fusion system instruments in the field.
Code information: Model No. 17-5A-DV45, 17-5A-DV60; UDI: 00843511122041, 00843511122058, 00843511122065.
Distribution pattern: US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Derived failure modes
-
Unknown
Failure of fusion system instruments in the field.