FDA Medical Device Recalls (openFDA)
Epic Extremity, LLC: 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)
- Recall number
- Z-1875-2018
- Recalling firm
- Epic Extremity, LLC
- 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)
- Status
- Terminated
- Initiated
- 2018-03-20
- Posted
- not on file
- Terminated
- 2019-04-25
- Reason
- There is an error in the caddy artwork that misidentifies a specific plate and screw.
- Root cause
- 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
- 9 units
- Distribution
- The products were distributed to the following US states: FL, PA, and VA.
- Lot, serial or model codes
- Catalog Number: 2111-1010 Lot: 51461
- 510(k) numbers
- ["K153340"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3012453147
- Firm city
- Cranberry Twp
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28