PlainRecalls
FDA Devices Moderate Class II Ongoing

TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.

Reported: September 17, 2025 Initiated: July 15, 2024 #Z-2557-2025

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.

Details

Recalling Firm
Omnia Medical
Units Affected
15 units
Distribution
US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Location
Morgantown, WV

Frequently Asked Questions

What product was recalled?
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.. Recalled by Omnia Medical. Units affected: 15 units.
Why was this product recalled?
Failure of fusion system instruments in the field.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 17, 2025. Severity: Moderate. Recall number: Z-2557-2025.