Z-1874-2018 Class II Terminated
FDA device recall Z-1874-2018 was initiated by Epic Extremity, LLC on March 20, 2018 and is designated Class II. Reason for recall: There is an error in the caddy artwork that misidentifies a specific plate and screw. The recall status is terminated (terminated April 25, 2019). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- March 20, 2018
- Termination Date
- April 25, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
Reason for Recall
There is an error in the caddy artwork that misidentifies a specific plate and screw.
Distribution Pattern
The products were distributed to the following US states: FL, PA, and VA.
Code Information
Catalog Number: 2111-0005 Lot: 51464