FDA-Device2025-09-17Class II
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
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, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2556-2025Don't want to check this manually?
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