Z-2557-2025 Class II Ongoing
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.