BEUDAMED
    FDA Enforcement Class II Ongoing

    smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

    Recall: Z-0277-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0277-2025
    Event ID
    95493
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 6, 2024
    Initiation Date
    October 2, 2024
    Classification Date
    October 30, 2024
    Address
    6409 E Holmes Rd, N/A, Memphis, TN, 38141-8310, United States

    Description

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

    Code Info

    UDI/DI 03596010543820, Batch Number 23LM00479

    Distribution

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

    Quantity

    3 units