Omnia Medical recalls TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
- Recall date
- July 15, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2556-2025
- FDA classification
- Class II
- Brand / firm
- Omnia Medical
- Sold / distributed
- US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Why it was recalled
Failure of fusion system instruments in the field.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
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