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Terminated

Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)

FDA Recall Z-1874-2018 · Posted None

Recalling FirmEpic Extremity, LLC
Recall StatusTerminated
Product CodeHRS
Date Initiated2018-03-20
Date Terminated2019-04-25
Product Quantity6 units

Reason for Recall

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

Firm 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 [email protected]. The notification letter included photographs of products to indicate errors in labeling.

Root Cause

Error in labeling

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153340Epic Extremity Plate SystemEpic Extremity, LLC · 2016-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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