BEUDAMED
    FDA Recall Terminated

    LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.

    Recall: Z-1951-2021 · Initiated May 19, 2021

    Recall

    Recall Number
    Z-1951-2021
    Event Number
    88010
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 19, 2021
    Terminated
    April 14, 2023
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.

    Reason

    The device components experienced a manufacturing process error that resulted in surface damage from product handling.

    Action

    On 5/19/2021, the firm issued letters dated 5/19/2021 via overnight mail or via email explaining the issue, potential risk of use of the product, and required actions, which are listed on the response form.

    Distribution

    US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.

    Quantity

    5 units