FDAFDA · Food and drugs·Recall number Z-1874-2018
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
Published May 23, 2018 · Recall initiated: March 20, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is an error in the caddy artwork that misidentifies a specific plate and screw.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Epic Extremity, LLC
- Distributor
- The products were distributed to the following US states: FL, PA, and VA.
- Lot
- Catalog Number: 2111-0005 Lot: 51464
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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