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SpineFrontier, Inc. recalls PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset
Recalled January 1, 2014 · FDA recall Z-0553-2014 · SpineFrontier
Hazard
Screw inserters may not mate properly with hex interface of the screws. · FDA Class II
Units
4
Sold at
US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
Description
Screw inserters may not mate properly with hex interface of the screws.
Product
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 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.
Manufacturer(s)
SpineFrontier, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →