BEUDAMED
    FDA Enforcement Class II Terminated

    Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.

    Recall: Z-2762-2019 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-2762-2019
    Event ID
    83689
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2019
    Initiation Date
    August 21, 2019
    Classification Date
    September 27, 2019
    Termination Date
    July 20, 2020
    Address
    Sulzerallee 8, N/A, Winterthur, N/A, N/A, Switzerland

    Description

    Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.

    Reason

    Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.

    Code Info

    Lot # 2941696 UDI: (01) 00889024415973 (17) 280299 (10) 2941696

    Distribution

    Worldwide distribution - iUS Nationwide distribution including states of AL, CO, KS, NJ, NY, OH, and OK, and countries of Belgium, Czech Republic, France, Germany, Switzerland, and United Kingdom.

    Quantity

    19 unit worldwide