FDA-Device2018-05-23Class II

Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)

Epic Extremity, LLC
Hazard

There is an error in the caddy artwork that misidentifies a specific plate and screw.

Sold states
The products were distributed to the following US states: FL, PA, and VA.
Affected count
6 units
Manufactured in
120 Marguerite Dr Ste 301, Cranberry Twp, PA, United States
Products
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1874-2018

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