Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver Recalled by Orthofix, Inc. Due to Orthofix received 6 complaints which resulted in a...
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
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
Quantity: 443
Why Was This Recalled?
Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Orthofix, Inc.
Orthofix, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report