Morgantown, WV, United States
Omnia Medical recalls
1 recall recorded since 2018, most recently on 15 July 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 July 2024
- Reason
- Failure of fusion system instruments in the field.
- Distribution
- US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2557-2025, Z-2556-2025
- TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
- TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.