Orthofix U.S. recalled 19,431 units of its FIREBIRD SI Fusion System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Affected models include multiple sizes of FIREBIRD SI Screws, sold worldwide.
Labeling contains claims that are not consistently present.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: E-Mail
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The recalled product includes model numbers 18-1025SP through 18-2070SP, with sizes ranging from 11mm to 12mm in diameters. The products were distributed widely across the United States and in several countries including Australia and Germany. The recall affects a total of 19,431 units.
The recall is due to labeling inconsistencies that could lead to improper use of the device. Such discrepancies pose significant risks to patients relying on accurate information for proper application.
No specific incidents or injuries related to this recall have been reported. The potential for harm is classified as high due to the device's medical application.
Stop using the FIREBIRD SI Fusion System immediately. Contact Orthofix U.S. LLC or your healthcare provider for further instructions on returning the product.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0894-2026 or contact Orthofix U.S. LLC directly.
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