Z-0589-2015Class II

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee...

Name: Z-0589-2015 LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee...
Creator: Smith & Nephew, Inc.
Published: 2014-11-04
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2014-11-04 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic on 2014-11-04. FDA classified it as Class II and gives the reason as "The stem taper on this device is undersized; the gauge point is not deep enough". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0589-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Posted: 2014-12-12
Terminated: 2019-08-22
Recalling firm: Smith & Nephew, Inc.
Product: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The stem taper on this device is undersized; the gauge point is not deep enough.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Smith & Nephew, Inc., sent an "Urgent-Product Recall 1st Notification-Urgent" letter dated 11/4/ 2014 to its customers via E-mail on 11/4/2014. International distributors were notified on 11/4/2014 by Email. Non-responding consignees will be contacted on 11/25/2014 by original method. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices and immediately quarantine; complete and return the Inventory Return Certification Form via fax to: +1-901-566-7975, even if you do not have product to return; contact Smith & Nephew's Safety Affairs Department via email at [email protected] or fax +1-901-566-7975 to obtain return authorization (RA) number; and return affected product to Smith & Nephew, Attn: Global Field Actions, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, please contact the Group Director, Quality Assurance +1-901-399-1970.
Quantity in commerce: 24 units
Distribution: Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.
Product codes and lots: Lot Number 14FM05730

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0589-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0589-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-11
Z-0590-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-11
Z-0591-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-11

Product code JWH

K060742Class IILegion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc. / cleared 2006-05-03

MDM coverage of this record lists here, newest first.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)