BEUDAMED
    FDA Recall Open, Classified

    smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic

    Recall: Z-0281-2025 · Initiated October 2, 2024

    Recall

    Recall Number
    Z-0281-2025
    Event Number
    95494
    Firm
    Smith & Nephew Inc
    FEI Number
    3005551626
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    October 2, 2024
    Posted
    October 31, 2024
    Address
    6409 E Holmes Rd, Memphis, TN, 38141-8310

    Description

    smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic

    Reason

    Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT 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. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 1450 E Brooks Road, Building G | Memphis, TN 38116 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 states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada

    Quantity

    5 units