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 FIREBIRD SI Fusion System is used in various orthopedic applications, providing support and stabilization during recovery. Consumers typically purchase this product based on its medical necessity for surgical procedures.
The issue arises from labeling that may mislead healthcare providers and patients, potentially affecting treatment decisions. Accurate labeling is crucial for patient safety in medical devices.
This recall is not part of a broader industry pattern.
Consumers may experience delays in treatment or recovery due to the recall. The urgency to stop using the product is essential to ensure patient safety.
Model numbers can typically be found on the product label or accompanying documentation.
Expect a refund or replacement within 4-6 weeks after submitting your return request.
Keep copies of receipts, emails, and any correspondence related to the recall for your records.
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.
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