Firebird SI FusionRecalls & reported problems across all models
Orthofix US LLC · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Firebird SI Fusion model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 20 models of Firebird SI Fusion by Orthofix US LLC in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Expiration Date Error” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Firebird SI Fusion recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 3, 2025Open, Classified
Labeling contains claims that are not consistently present.
Z-0894-2026 · Root cause: Device Design · names 20 of these models · Recall details · FDA record ↗
Most reported Firebird SI Fusion problems
Device problems
- Expiration Date Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Firebird SI Fusion models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Firebird SI Fusion 18-1035SPSacroiliac Joint Fixation1 recall1 report
- Firebird SI Fusion 18-1025SPSacroiliac joint fixation1 recall0 reports
- Firebird SI Fusion 18-1030SPSacroiliac joint fixation1 recall0 reports
- Firebird SI Fusion 18-1040SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1050SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1055SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1060SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1065SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1070SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2025SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2030SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2035SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2040SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2045SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2050SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2055SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2060SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2065SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2070SPSacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1045SPSacroiliac Joint Fixation1 recall0 reports
Recent Firebird SI Fusion adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 22, 2026Expiration Date Error
AS PER THE REPORTER AN EXPIRED 18-1035SP WAS IMPLANTED IN THE PATIENT. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956899 ↗
Other Orthofix US LLC products
- CONNECTOR2 models · 0 reports · 2 recalls
- FORZA PTC76 models · 3 reports · 1 recall
- CONSTRUX - MINI PTC70 models · 0 reports · 1 recall
- PILLAR SA PTC16 models · 0 reports · 1 recall
- FORZA Ti91 models · 0 reports · 1 recall
- CONSTRUX - MINI Ti112 models · 0 reports · 1 recall
- PILLAR SA Ti3 models · 0 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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