FDA-Device2018-05-23Class II

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)

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
9 units
Manufactured in
120 Marguerite Dr Ste 301, Cranberry Twp, PA, United States
Products
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)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1875-2018

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