Z-0277-2025Class II

smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS...

Name: Z-0277-2025 smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS...
Creator: Smith & Nephew Inc
Published: 2024-10-02
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2024-10-02 / Open, Classified / root cause: packaging

FDA source

Smith & Nephew Inc began a recall of smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED... on 2024-10-02. FDA classified it as Class II and gives the reason as "Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0277-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-02
Posted: 2024-10-30
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Smith & Nephew issued an "Urgent Medical Device Recall Notice" to its consignees on 10/02/2024 via email. The notice explained the issue, potential risk of use of the affected product, and requested the return of the affected devices. Distributors, sales reps, and district offices were directed to notify their customers. If you have any questions or concerns regarding this recall please contact FieldActions@smith nephew.com.
Quantity in commerce: 3 units
Distribution: US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
Product codes and lots: UDI/DI 03596010543820, Batch Number 23LM00479

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0277-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0277-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30
Z-0278-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30

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