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SpineFrontier, Inc. recalls Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Pla
Recalled August 14, 2013 · FDA recall Z-1927-2013 · SpineFrontier
Hazard
Device design. · FDA Class II
Units
12 devices
Sold at
Nationwide Distribution including Texas, Ohio, and Missouri.
Description
Device design.
Product
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.
Manufacturer(s)
SpineFrontier, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →