Medical device recalls Moderate risk

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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