BEUDAMED
    FDA Recall Open, Classified

    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA

    Recall: Z-2126-2025 · Initiated June 2, 2025

    Recall

    Recall Number
    Z-2126-2025
    Event Number
    97048
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    June 2, 2025
    Posted
    July 17, 2025
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445

    Description

    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA

    Reason

    Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

    Action

    On 06/02/2025, the firm emailed an "Urgent: Medical Device Recall" letter to customers. The letter described the product, problem and actions to be taken. Customers are instructed to: 1.Review their stock for the products and lot numbers for the items to be returned. 2.This notice needs to be passed on to all those within their organization or to any organization where the product has been transferred. 3.Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through their regional email address, to place a replacement request. They will be provided with an RMA number and shipping label to return the affected product. 4.Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. Any questions, contact Recall Coordinator at [email protected] or call/text 682-299-9133.

    Distribution

    U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA

    Quantity

    20