Quick Facts at a Glance
- Recall Date
- July 15, 2024
- Hazard Level
- HIGH
- Brands
- Omnia Medical, TiBrid
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Omnia Medical, TiBrid
- Product type
- Intervertebral Fusion Device and Tools
- Model numbers
- 17-5A-DV45, 17-5A-DV60, 00843511122041, 00843511122058, 00843511122065
- Colors
- Unknown
- Sizes
- Unknown
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 15, 2024
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failure of fusion system instruments in the field.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Omnia Medical or your healthcare provider for instructions. Notification method: Telephone
About This Product
TiBrid devices are used in spinal fusion procedures. They are designed to stabilize the spine during fusion.
Why This Is Dangerous
Field-instrument failure can compromise the fusion procedure and pose risk to patients during surgery.
Industry Context
This recall is not clearly described as part of a broader industry pattern in the provided data.
Real-World Impact
This recall could cause surgical delays or changes in planned fusion surgeries, requiring clinicians to switch instruments mid-procedure.
Practical Guidance
How to identify if yours is affected
- Check if your facility uses TiBrid Stand Alone Intervertebral Body Fusion Device or TiBrid SA Angled Screwdrivers.
- Review distribution notes to confirm if your case involved AZ, CA, NJ, NV, OK or WA.
Where to find product info
Refer to the FDA enforcement report page for Z-2557-2025 recall details.
What timeline to expect
Remedy processing timelines are determined by Omnia Medical per recall instructions.
If the manufacturer is unresponsive
- Document outreach attempts
- Escalate to hospital risk management or compliance
- File a formal report with the manufacturer and FDA if needed
How to prevent similar issues
- Verify device recalls before procedures
- Maintain an updated list of implanted devices and associated lot numbers
- Establish supplier recall notification protocols
Documentation advice
Keep recall notices, model numbers, distribution list, and communication records
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Product Details
Brand: Omnia Medical. Product: TiBrid Stand Alone Intervertebral Body Fusion Device and TiBrid SA Angled Screwdrivers (30°, 45°, 60° angles). Models include 17-5A-DV45, 17-5A-DV60, 00843511122041, 00843511122058, 00843511122065. Quantity: 15 units. Distribution: US Nationwide in AZ, CA, NJ, NV, OK, WA. Status: Active recall. Recall date: 2024-07-15.
Reported Incidents
No specific injuries or incidents are detailed in the provided data.
Key Facts
- US nationwide distribution in AZ, CA, NJ, NV, OK, WA
- Hazard: Field-instrument failure
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Safety Guide
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