# FDA recall Z-0277-2025

> **Smith & Nephew Inc** · Class II · device recall initiated 2024-10-02.

## Product

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

## Distribution

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

## Key facts

- **Recall number:** Z-0277-2025
- **Recalling firm:** Smith & Nephew Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-02
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2025

## Citation

> AI Analytics. FDA recall Z-0277-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0277-2025. Source: US FDA. Licensed CC0.

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