Medical device recalls Moderate risk

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

Recall date
March 20, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1874-2018
FDA classification
Class II
Brand / firm
Epic Extremity, LLC
Sold / distributed
The products were distributed to the following US states: FL, PA, and VA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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