FDA recall Z-1875-2018

Epic Extremity, LLC · Class II · device

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)

Reason for recall

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

Distribution

The products were distributed to the following US states: FL, PA, and VA.

Key facts

Status
Terminated
Initiation date
2018-03-20
Report date
2018-05-23
Termination date
2019-04-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cranberry Twp, PA, United States

Primary source

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