FDA-Device2014-01-01Class II
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.
SpineFrontier, Inc.
Hazard
Screw inserters may not mate properly with hex interface of the screws.
Sold states
US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
Affected count
4
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0553-2014Don't want to check this manually?
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