The Recall Desk

FDA (Devices) recall action 79824

Epic Extremity, LLC recalled 2 products on 2018-05-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-05-23
Critical
0
Units
15

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2018-05-23

    Epic Extremity Plate System Caddy Recalled for Artwork Error

    Epic Extremity, LLC is recalling 9 units of the 10x10 Plate Caddy due to an artwork error that misidentifies a specific plate and screw.

    Product
    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)
    Category
    Distribution
    3 states
  • LowFDA (Devices)··2018-05-23

    Epic Extremity Plate System Recalled for Packaging Labeling Error

    Epic Extremity, LLC is recalling 6 units of the Epic Extremity Plate System due to a packaging error that misidentifies a specific plate and screw.

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