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U.S. Department of Health and Human Services

Class 2 Device Recall Epic Extremity Plate System

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  Class 2 Device Recall Epic Extremity Plate System see related information
Date Initiated by Firm March 20, 2018
Create Date May 15, 2018
Recall Status1 Terminated 3 on April 25, 2019
Recall Number Z-1874-2018
Recall Event ID 79824
510(K)Number K153340  
Product Classification Plate, fixation, bone - Product Code HRS
Product Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
Code Information Catalog Number: 2111-0005 Lot: 51464
Recalling Firm/
Epic Extremity, LLC
120 Marguerite Dr Ste 301
Cranberry Twp PA 16066-5007
For Additional Information Contact Dan Schwartzbauer
Manufacturer Reason
for Recall
There is an error in the caddy artwork that misidentifies a specific plate and screw.
FDA Determined
Cause 2
Error in labeling
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.
Quantity in Commerce 6 units
Distribution The products were distributed to the following US states: FL, PA, and VA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = Epic Extremity, LLC