---
title: "smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 L... — FDA record Z-0278-2025 | Is It on Recall"
description: "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 produc"
url: https://isitonrecall.com/recall/fda-device-z-0278-2025-smith-nephew-leigon-oxinium-constrained-nonporous-femoral-component-size-4-left-ref-71421164-prosthe/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PAT... — FDA record Z-0278-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 2, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Smith & Nephew Inc
- **Quantity**: 2 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0278-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0278-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI/DI 03596010543837, Batch Number 23LM03388 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Nov 6, 2024
- **Recall initiation date**: Oct 2, 2024
- **Center classification date**: Oct 30, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0278-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Smith & Nephew, Inc. records](https://isitonrecall.com/brand/smith-nephew-inc/)