TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
This recall is currently active, issued September 11, 2025.
- Recall Initiated
- July 15, 2024
- Posted
- September 11, 2025
- Recall Number
- Z-2557-2025
- Quantity
- 15 units
- Firm Location
- Morgantown, WV
- Official Source
- View on FDA website ↗
Reason for Recall
Failure of fusion system instruments in the field.
Distribution
US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Lot / Code Info
Model No. 17-5A-DV45, 17-5A-DV60; UDI: 00843511122041, 00843511122058, 00843511122065.
Root Cause
Device Design
Action Taken
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.