The Recall Desk
HighFDA (Devices)·Z-0894-2026·Announced 2025-12-17

[pending] Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Numb

Pending LLM rewrite. Source: FDA_DEVICE Z-0894-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Labeling contains claims that are not consistently present.

The recalled product

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; 18-1045S
Manufacturer
Orthofix U.S. LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category