Quick Facts at a Glance
- Recall Date
- July 15, 2024
- Hazard Level
- HIGH
- Brand
- Omnia Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Product type
- Intervertebral Fusion Instrumentation
- Model numbers
- 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5, UDI: 00843511113056, 00843511122287, 00843511122294
- Sizes
- 30 degree, 45 degree, 60 degree
- 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
The TiBrid device is used in spinal fusion procedures and relies on specialized instruments for operation.
Why This Is Dangerous
The instruments used with the fusion device can fail in the field, potentially compromising the procedure.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Direct impact on surgeons and patients; potential procedure disruption and need for reoperation depending on instrument failure.
Practical Guidance
How to identify if yours is affected
- Verify model numbers: 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5
- Check distribution list for AZ, CA, NJ, NV, OK, WA
Where to find product info
FDA recall page linked in data; manufacturer recall instructions
What timeline to expect
Actions are immediate; refunds/replacements depend on Omnia Medical processing
If the manufacturer is unresponsive
- Escalate to regulatory authorities if manufacturer is unresponsive
- Consult hospital risk management for interim patient safety measures
How to prevent similar issues
- Ensure any facilities using the TiBrid system are aware
- Confirm instrument integrity before procedures
- Maintain updated recall contact channels
- Document all communications and actions
Documentation advice
Keep recall notification, model and UDI references, hospital communications, and any instrument failure reports
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Product Details
Product: TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl. Models: 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5. UDI: 00843511113056, 00843511122287, 00843511122294. Quantity: 15 units. Distribution: US nationwide in AZ, CA, NJ, NV, OK, WA. Distributor/brand: Omnia Medical.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Active recall as of 2025-09-17
- Models 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5
- Distributed nationwide in AZ, CA, NJ, NV, OK, WA
- Manufacturer: Omnia Medical
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Safety Guide
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