BEUDAMED
    FDA Enforcement Class II Ongoing

    EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H

    Recall: Z-0103-2024 · Reported October 18, 2023

    Enforcement

    Recall Number
    Z-0103-2024
    Event ID
    93098
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 18, 2023
    Initiation Date
    August 22, 2023
    Classification Date
    October 12, 2023
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H

    Reason

    Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

    Code Info

    UDI-DI: 00190446309833, Lot: 629Z1114, Expiration: March 30, 2028

    Distribution

    US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.

    Quantity

    20