[Recalled] TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles. — Failure of fusion system instruments in the field | FDA 2024-07-15
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles. |
|---|---|
| Brand / manufacturer | Omnia Medical |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2557-2025 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 15 July 2024 |
| EAN / barcode | 00843511122041 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Failure of fusion system instruments in the field.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.