BEUDAMED
    FDA Recall Open, Classified

    smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

    Recall: Z-0278-2025 · Initiated October 2, 2024

    Recall

    Recall Number
    Z-0278-2025
    Event Number
    95493
    Firm
    Smith & Nephew Inc
    FEI Number
    3005551626
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    October 2, 2024
    Posted
    October 30, 2024
    Address
    6409 E Holmes Rd, Memphis, TN, 38141-8310

    Description

    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.

    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.

    Distribution

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

    Quantity

    2 units