BEUDAMED
    FDA Enforcement Class II Terminated

    Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.

    Recall: Z-0644-2019 · Reported December 26, 2018

    Enforcement

    Recall Number
    Z-0644-2019
    Event ID
    81608
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2018
    Initiation Date
    October 31, 2018
    Classification Date
    December 20, 2018
    Termination Date
    April 1, 2020
    Address
    Sulzerallee 8, Winterthur, N/A, Switzerland

    Description

    Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.

    Reason

    Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .

    Code Info

    Lot Number:2955599 UDI Number:(01) 00889024479456(17)230831(10)2955599

    Distribution

    International distribution in the countries of Germany and Switzerland.

    Quantity

    13 units