BEUDAMED
    FDA Recall Open, Classified

    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 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.

    Recall: Z-2286-2025 · Initiated July 9, 2025

    Recall

    Recall Number
    Z-2286-2025
    Event Number
    97188
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    July 9, 2025
    Posted
    August 8, 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 KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 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.

    Reason

    Knee implants contain incorrect labeling (size and/or side incorrect)

    Action

    On January 15, 2026 Enovis (Encore Medical, L.P.) issued a Urgent: Medical Device Recall expansion notification to affected consignees via Email. The expansion notification included additional lots of affected product. Initial notification was sent out on July 9, 2025. Enovis asked consignees to take the following actions: 1. Review your stock for the products and lot numbers for the items to be returned. 2. Remove any indicated product from stock and quarantine. 3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. You will be provided with an RMA number and shipping label to return the affected product. 5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.

    Quantity

    40 implants