Z-1507-2020Class II

LEGION PS High Flex XLPE size 5-6 9mm Articular Insert

Name: Z-1507-2020 LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Creator: Smith & Nephew, Inc.
Published: 2019-12-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2019-12-19 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of LEGION PS High Flex XLPE size 5-6 9mm Articular Insert on 2019-12-19. FDA classified it as Class II and gives the reason as "LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part". 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-1507-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-19
Posted: 2020-03-17
Terminated: 2024-09-04
Recalling firm: Smith & Nephew, Inc.
Product: LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by letter on January 6, 2020. The letter identified the problem and directed the consignee to quarantine the devices. The notice instructs to complete and return the response form and to make arrangement for the return of affected product. For any questions or concerns please contact: [email protected].
Quantity in commerce: 29 units
Distribution: USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).
Product codes and lots: Lot Number 19FM12500; Product Number 71453221.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1507-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1507-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-17

Product code JWH

K071071Class IICrosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. / cleared 2007-09-19

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)