BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589

    Recall: Z-1615-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1615-2020
    Event ID
    85143
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 8, 2020
    Initiation Date
    February 25, 2020
    Classification Date
    March 31, 2020
    Termination Date
    August 5, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589

    Reason

    Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.

    Code Info

    Lot Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420

    Distribution

    International distribution - country of Netherland.s

    Quantity

    21 units