Z-1820-2009

LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The...

Name: Z-1820-2009 LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The...
Creator: Smith & Nephew Inc
Published: 2009-01-22
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2009-01-22 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants on 2009-01-22. The reason FDA records is "Products were mispackaged". 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-1820-2009
Status: Terminated
Initiated: 2009-01-22
Posted: 2009-08-23
Terminated: 2012-02-07
Recalling firm: Smith & Nephew, Inc.
Product: LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Products were mispackaged.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All affected Smith & Nephew Sales Representatives were notified of the problem and the recall via email and overnight mail on January 22, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 22, 2009. They were instructed to immediately quarantine the product for return.
Quantity in commerce: 19 units
Distribution: Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.
Product codes and lots: Lot Number: 06DM08612.

Product code JWH

K043440Class IISmith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. / cleared 2005-02-18

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