Omnia Medical: Medical Device Recall in 2025 - (Recall #: Z-2556-2025)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2025.
Data Source: FDA.
Product Description:
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Product Classification:
Class II
Date Initiated: July 15, 2024
Date Posted: September 17, 2025
Recall Number: Z-2556-2025
Event ID: 97402
Reason for Recall:
Failure of fusion system instruments in the field.
Status: Ongoing
Product Quantity: 15 units
Code Information:
Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.
Distribution Pattern:
US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Voluntary or Mandated:
Voluntary: Firm initiated