Device product
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
Z-1874-2018
Product summary
- Event
- Event 79824
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1874-2018
Official wording
Reason: There is an error in the caddy artwork that misidentifies a specific plate and screw.
Code information: Catalog Number: 2111-0005 Lot: 51464
Distribution pattern: The products were distributed to the following US states: FL, PA, and VA.
Derived failure modes
-
Unknown
There is an error in the caddy artwork that misidentifies a specific plate and screw.