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

Sacroiliac fusion screws recalled over labeling claims not consistently present

Orthofix U.S. is recalling 19,431 FIREBIRD SI Fusion System units because the labeling contains claims that are not consistently present.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites inconsistent labeling claims with no stated product defect or consequence.

Plain-English summary

The FIREBIRD SI Fusion System from Orthofix U.S. LLC is being recalled, across a range of catalog numbers listed in the enforcement record including the 11mm x 25mm, 11mm x 30mm, 11mm x 35mm and 11mm x 40mm FIREBIRD SI screws.

The reason given in the enforcement record is that the labeling contains claims that are not consistently present.

The record lists 19,431 units across all lots. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class III, its least serious category.

The record describes an inconsistency in labeling claims rather than a product defect, and states no injuries. Facilities should follow Orthofix's instructions.

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 — Orthopedic implant
Hazard
  • labeling-inconsistency
  • sacroiliac-fusion
  • class-iii

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.

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