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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Omnia Medical TiBrid Fusion System Instruments Recalled for Field Failures

Agency Publication Date: September 11, 2025
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Summary

Omnia Medical is recalling 15 units of its TiBrid Stand Alone Intervertebral Body Fusion Device instruments, including SA Angled Punch Awls and Angled Screwdrivers. The recall was initiated following reports of instrument failures during clinical use in the field. These instruments are specialized tools used by surgeons during spinal fusion procedures.

Risk

The instruments may fail or break while in use during surgery. This can result in surgical delays, incomplete procedures, or the need for additional surgical intervention to address the failure or retrieve broken components.

What You Should Do

  1. This recall involves TiBrid Stand Alone Intervertebral Body Fusion Device instruments, specifically SA Angled Punch Awls and SA Angled Screwdrivers in 30, 45, and 60-degree sizes.
  2. Identify affected instruments by checking the model numbers and Unique Device Identifier (UDI) codes on the product labeling. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Omnia Medical or your distributor to arrange for the return, replacement, or correction of the instruments.
  5. Call the FDA at 1-888-463-6332 for additional questions or to report a complaint.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl
Variants: 30 degree, 45 degree, 60 degree
Model / REF:
17-5A-AWL3
17-5A-AWL4
17-5A-AWL5
UDI:
00843511113056
00843511122287
00843511122294

Quantity: 15 units

Product: TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers
Variants: 30 degree, 45 degree, 60 degree
Model / REF:
17-5A-DV45
17-5A-DV60
UDI:
00843511122041
00843511122058
00843511122065

Quantity: 15 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97402
Status: Active
Manufacturer: Omnia Medical
Sold By: Hospitals; Surgical Centers; Medical Device Distributors
Manufactured In: United States
Units Affected: 2 products (15 units)
Distributed To: Arizona, California, New Jersey, Nevada, Oklahoma, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.