Skip to content

Firebird SI Fusion 18-2045SPRecalls & reported problems

Orthofix US LLC · 12MM X 45MM 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
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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.

Recalls naming this device

  1. Nov 3, 2025Class IIIOpen, Classified

    Labeling contains claims that are not consistently present.

    Z-0894-2026 · Root cause: Device Design · Recall details · FDA record ↗

Other Sacroiliac Joint Fixation devices

All Sacroiliac Joint Fixation devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page