BEUDAMED
    FDA Enforcement Class II Terminated

    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

    Recall: Z-2003-2016 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-2003-2016
    Event ID
    74206
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    May 17, 2016
    Classification Date
    June 16, 2016
    Termination Date
    October 31, 2016
    Address
    Sulzer Allee 8, Winterthur, N/A, Switzerland

    Description

    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

    Reason

    In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.

    Code Info

    Item Number: 01.04227.005 Lot Numbers: 2792457 2794578 2812029 2817212 2844463 2794576 2794579 2815118 2817213 2847568 2794577 2794580 2815119 2832862

    Distribution

    Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.

    Quantity

    177