Recall Z-1875-2018— Epic Extremity, LLC

Name: FDA recall Z-1875-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-20

Class II · Terminated

Class II FDA medical device recall by Epic Extremity, LLC, initiated 2018-03-20, terminated 2019-04-25. It names one FDA 510(k) clearance: K153340. 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: There is an error in the caddy artwork that misidentifies a specific plate and screw..

Recalling firm: Epic Extremity, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-03-20
Terminated: 2019-04-25
Firm location: Cranberry Twp, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K153340 — Epic Extremity Plate SystemEpic Extremity, LLC·cleared 2016-02-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.