BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 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-2285-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2285-2025
    Event ID
    97188
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2025
    Initiation Date
    July 9, 2025
    Classification Date
    August 8, 2025
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 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)

    Code Info

    Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057

    Distribution

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

    Quantity

    18 implants