Z-2557-2025 Class II Ongoing
FDA device recall Z-2557-2025 was initiated by Omnia Medical on July 15, 2024 and is designated Class II. Reason for recall: Failure of fusion system instruments in the field. The recall status is ongoing. Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2025
- Initiation Date
- July 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Reason for Recall
Failure of fusion system instruments in the field.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Code Information
Model No. 17-5A-DV45, 17-5A-DV60; UDI: 00843511122041, 00843511122058, 00843511122065.