FDAFDA · Food and drugs·Recall number Z-0555-2014
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Published January 1, 2014 · Recall initiated: November 20, 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
Screw inserters may not mate properly with hex interface of the screws.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
- Lot
- VM13222- 34489
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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