Medical device recalls Moderate risk

Epic Extremity, LLC recalls Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-…

Recall date
March 20, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1875-2018
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,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)

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