Z-2945-2020Class II

EVOS Screws -

Name: Z-2945-2020 EVOS Screws -
Creator: Smith & Nephew, Inc.
Published: 2020-08-24
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-08-24 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. began a recall of EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction... on 2020-08-24. FDA classified it as Class II and gives the reason as "Multiple or incorrect expiration dates were provided on the affected designation labels". 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-2945-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-24
Posted: 2020-09-09
Terminated: 2022-07-11
Recalling firm: Smith & Nephew, Inc.
Product: EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Multiple or incorrect expiration dates were provided on the affected designation labels.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On August 24th the firm sent via email a notification to affected consignees. Consignees are asked to inspect inventory, locate and quarantine affected devices. Sales Reps and or distributors are instructed to notify customers of the field action and ensure required actions are complete. Affected product will be returned to Smith & Nephew. All consignees are asked to complete a Response Form, even if they do not have product to return.
Quantity in commerce: 71 units
Distribution: International Distribution to the countries of Denmark, Sweden, France and Spain.
Product codes and lots: Part Numbers: 72424030, 72424010, 72424012, 72424016, 72424018, 72424020, 72424022, 72424024, 72434026, 72434028, 72434030, 72423014, 72423016, 72434065, 72434070, 72434075, 72412465, 72424032, 72424040, 72424055, 72424075, 72424080, 72423044. Batch/Lots: 14FM17199R, 14FM01226R, 14FM01227R, 14FM02610R, 14FM03418R, 14FM03420R, 14FM03422R, 14FM03424R, 14FM13578R, 14FM13580R, 14FM13581R, 14FM15166R, 14FM15167R, 14FM16225R, 14FM16228R, 14FM16229R, 14FM16386R, 14FM17201R, 14FM18527R, 14FM19218R, 14FM19226R, 14FM19229R, 14FM19360R.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2945-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2945-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-16	2020-09-09

Product code HRS

K140814Class IIEvos Mini-Fragment Plating SystemSmith & Nephew, Inc. / cleared 2014-05-07

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)