Events

Recall of Device Recall Epic Extremity Plate System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Epic Extremity, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79824
  • Event Risk Class
    Class 2
  • Event Number
    Z-1874-2018
  • Event Initiated Date
    2018-03-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163592
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Plate, fixation, bone - Product Code HRS
  • Reason
    There is an error in the caddy artwork that misidentifies a specific plate and screw.
  • Action
    Notification letters were sent on 3/20/18. The letters instructed customers to: We ask you to be aware of the incorrect numbers and ensure you are ordering the correct part numbers until replacement parts are available. You will be informed promptly of the availability of the replacement trays. You will be contacted to arrange return and to exchange the parts presently in your possession. Our records indicate that you have received one or more of the trays involved. Therefore, we would ask you to reply to this memo and confirm the quantities of each tray in your possession. Your response will serve as acknowledgement of this notification and that you will act in compliance. Please reply to dschwartzbauer@EPICextremity.com. The notification letter included photographs of products to indicate errors in labeling.

Device

Device Recall Epic Extremity Plate System
  • Model / Serial
    Catalog Number: 2111-0005 Lot: 51464
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were distributed to the following US states: FL, PA, and VA.
  • Product Description
    Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
  • Manufacturer
    Epic Extremity, LLC

Manufacturer

Epic Extremity, LLC
  • Manufacturer Address
    Epic Extremity, LLC, 120 Marguerite Dr Ste 301, Cranberry Twp PA 16066-5007
  • Source
    USFDA