BEUDAMED
    FDA Enforcement Class II Ongoing

    EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.

    Recall: Z-0135-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0135-2021
    Event ID
    86450
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 28, 2020
    Initiation Date
    September 9, 2020
    Classification Date
    October 20, 2020
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.

    Reason

    Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.

    Code Info

    Model Number: 940-02-54G Lot Number: 801Z1036

    Distribution

    U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.

    Quantity

    12 cups