Z-2556-2025 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, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
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-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.