Z-1875-2018Class II

Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw...

Name: Z-1875-2018 Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw...
Creator: Epic Extremity, LLC
Published: 2018-03-20
License: https://open.fda.gov/license/

Epic Extremity, LLC / initiated 2018-03-20 / Terminated / root cause: labeling and UDI

FDA source

Epic Extremity, LLC began a recall of 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) on 2018-03-20. FDA classified it as Class II and gives the reason as "There is an error in the caddy artwork that misidentifies a specific plate and screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1875-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-20
Posted: 2018-05-15
Terminated: 2019-04-25
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)
Product code: HRS Plate, Fixation, Bone
Reason for recall: There is an error in the caddy artwork that misidentifies a specific plate and screw.
Root cause tag: labeling and UDI
FDA 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 [email protected]. The notification letter included photographs of products to indicate errors in labeling.
Quantity in commerce: 9 units
Distribution: The products were distributed to the following US states: FL, PA, and VA.
Product codes and lots: Catalog Number: 2111-1010 Lot: 51461

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1875-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1874-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15
Z-1875-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-15

Product code HRS

K153340Class IIEpic Extremity Plate SystemEpic Extremity, LLC / cleared 2016-02-09

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)