FDA-Device2025-09-17Class II
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Omnia Medical
Hazard
Failure of fusion system instruments in the field.
Sold states
US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Affected count
15 units
Manufactured in
6 Canyon Rd Ste 300, N/A, Morgantown, WV, United States
Products
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2557-2025Don't want to check this manually?
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