Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- Orthofix U.S.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Orthofix U.S.
- Product type
- Fusion System
- Model numbers
- Lot Code: All Lots/ UDI: 18-1025SP 18257200140084, 18-1030SP 18257200140091, 18-1035SP 18257200140107, 18-1040SP 18257200140114, 18-1045SP 18257200140275, 18-1050SP 18257200140121, 18-1055SP 18257200140138, 18-1060SP 18257200140145 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling contains claims that are not consistently present.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The FIREBIRD SI Fusion System is used in various orthopedic applications, providing support and stabilization during recovery. Consumers typically purchase this product based on its medical necessity for surgical procedures.
Why This Is Dangerous
The issue arises from labeling that may mislead healthcare providers and patients, potentially affecting treatment decisions. Accurate labeling is crucial for patient safety in medical devices.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may experience delays in treatment or recovery due to the recall. The urgency to stop using the product is essential to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Locate the model number on your product packaging or documentation.
- Compare your model to the recall list provided by Orthofix.
- Contact your healthcare provider if you are unsure about your product's status.
Where to find product info
Model numbers can typically be found on the product label or accompanying documentation.
What timeline to expect
Expect a refund or replacement within 4-6 weeks after submitting your return request.
If the manufacturer is unresponsive
- Document your communication attempts with Orthofix.
- Follow up via email or phone if you do not receive a timely response.
How to prevent similar issues
- Always check for recalls on medical devices before purchasing.
- Look for clear labeling and certifications on medical products.
- Consult with healthcare providers about the safety of medical devices.
Documentation advice
Keep copies of receipts, emails, and any correspondence related to the recall for your records.
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Product Details
The recalled product includes model numbers 18-1025SP through 18-2070SP, with sizes ranging from 11mm to 12mm in diameters. The products were distributed widely across the United States and in several countries including Australia and Germany. The recall affects a total of 19,431 units.
Key Facts
- Recall date: November 3, 2025
- Affected product quantity: 19,431 units
- Labeling inconsistencies present in all lots
- Devices sold worldwide
- No reported injuries or incidents
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Safety Guide
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