Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Firebird Spinal Fixation System Recalled by Orthofix, Inc Due to There is a possibility that the Set Screw...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Orthofix, Inc directly.
Affected Products
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
Quantity: 565 total (287 PN 52-6800 and 278 PN 52- 6700)
Why Was This Recalled?
There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Orthofix, Inc
Orthofix, Inc has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report