FDAFDA · Food and drugs·Recall number Z-0855-2014
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.
Published February 5, 2014 · Recall initiated: November 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthofix, Inc.
- Distributor
- Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
- Lot
- Production Identification Numbers: Part Number 52-1332, All Lot Numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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