TiBrid Stand Alone Intervertebral Body Fusion Device, SA… recallZ-2556-2025 · Omnia Medical · initiated Jul 15, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Omnia Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Failure of fusion system instruments in the field.
FDA root cause category: Device Design
What the company is doing
Consignees were called on or around 8/1/2024 to notify them of this recall of instruments. Affected instruments were to be sent back to Omnia Medical and replaced with instruments that underwent rework in the form of design changes aimed at increasing their durability.
Recall details
- Recall number
- Z-2556-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 15, 2024
- Posted by the FDA
- Sep 11, 2025
- Recalling firm
- Omnia Medical
- Quantity
- 15 units
- Product code
- OVD
- FDA submissions
- K203207
- Distribution
- US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Product description
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Code information (models, lots, serial numbers)
Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- TiBrid-SA 17-5A-AWL3Omnia Medical, LLC · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
- TiBrid-SA 17-5A-AWL4Omnia Medical, LLC · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
- TiBrid-SA 17-5A-AWL5Omnia Medical, LLC · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
Other devices under the same FDA submission
3 devices cleared under K203207 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TiBrid-SA 17-5A-DV30Omnia Medical, LLC · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
- TiBrid-SA 17-5A-DV45Omnia Medical, LLC · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
- TiBrid-SA 17-5A-DV60Omnia Medical, LLC · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97402).
- Z-2557-2025 · Open, ClassifiedTiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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