BEUDAMED
    FDA Enforcement Class II Terminated

    Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

    Recall: Z-1239-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1239-2018
    Event ID
    79400
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 4, 2018
    Initiation Date
    January 24, 2018
    Classification Date
    March 28, 2018
    Termination Date
    April 9, 2019
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

    Reason

    One lot of humeral stem implants do not include the humeral bushing components.

    Code Info

    Lot Number: 63694912

    Distribution

    Distributed in China and Taiwan.

    Quantity

    9