Firebird SI Fusion 18-1035SPRecalls & reported problems
Orthofix US LLC · 11MM X 35MM FIREBIRD SI SCREW, FIREBIRD SI FUSION SYSTEM, STERILE · Class 2 · Implant
All models of Firebird SI Fusion (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18257200140107), 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 this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Nov 3, 2025Class IIIOpen, Classified
Labeling contains claims that are not consistently present.
Z-0894-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Expiration Date Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, 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 Sacroiliac Joint Fixation devices
- iFuse TORQ Implant System 10065TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- iFuse TORQ Implant System 10060TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall1 report
- Firebird SI Fusion 18-2050SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-1065SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2065SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2045SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
- iFuse TORQ Implant System 10055TSi-Bone Inc. · Sacroiliac Joint Fixation1 recall0 reports
- Firebird SI Fusion 18-2025SPOrthofix US LLC · Sacroiliac Joint Fixation1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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