FDA recall Z-2556-2025

Omnia Medical · Class II · device

Product

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

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-2556-2025