FDA recall Z-2557-2025

Omnia Medical · Class II · device

Product

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

US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.

Key facts

Status
Ongoing
Initiation date
2024-07-15
Report date
2025-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2557-2025