FIREBIRD SI Fusion System (Orthofix) – inconsistent labeling (2025)
Downstream occlusion alarms may occur during low-flow infusion procedures with specific equipment.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI Screw; 18-1050SP 11mm X 50mm FIREBIRD SI Screw; 18-1055SP 11mm X 55mm FIREBIRD SI Screw; 18-1060SP 11mm X 60mm FIREBIRD SI Screw; 18-1065SP 11mm X 65mm FIREBIRD SI Screw; 18-1070SP 11mm X 70mm FIREBIR
Brand
Orthofix U.S. LLC
Lot Codes / Batch 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, 18-1065SP 18257200140152, 18-1070SP 18257200140169, 18-2025SP 18257200140176, 18-2030SP 18257200140183, 18-2035SP 18257200140190, 18-2040SP 18257200140206, 18-2045SP 18257200140213, 18-2050SP 18257200140220, 18-2055SP 18257200140237, 18-2060SP 18257200140244, 18-2065SP 18257200140251, 18-2070SP 18257200140268
Products Sold
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; 18-1065SP 18257200140152; 18-1070SP 18257200140169; 18-2025SP 18257200140176; 18-2030SP 18257200140183; 18-2035SP 18257200140190; 18-2040SP 18257200140206; 18-2045SP 18257200140213; 18-2050SP 18257200140220; 18-2055SP 18257200140237; 18-2060SP 18257200140244; 18-2065SP 18257200140251; 18-2070SP 18257200140268
Orthofix U.S. LLC is recalling Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number due to Labeling contains claims that are not consistently present.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling contains claims that are not consistently present.
Recommended Action
Per FDA guidance
On November 3, 2025 Orthofix issued a recall notification via Email to affected consignees. In addition to informing consignees about the recall , Orthofix ask consignees to take the following actions: 1. Orthofix is removing claims regarding Nanovate Technology in materials, including but not limited to Operative Techniques, Product Brochures, Medical Education Documents, and the Orthofix website. 2. No product return is being requested. You may continue to use the product. 3. Distribute this Notice to all relevant personnel within your organization. 4. Forward this Notice to other organization or facilities where affected products may have been transferred. 5. Acknowledge this Notice and return the completed receipt form to fieldactions@orthofix.com
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.