FDAFDA · Food and drugs·Recall number Z-1927-2013
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
Published August 14, 2013 · Recall initiated: May 10, 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
Device design.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- Nationwide Distribution including Texas, Ohio, and Missouri.
- Lot
- Lot/Serial Numbers: 027104, 027105
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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