BEUDAMED
    FDA Enforcement Class II Terminated

    Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

    Recall: Z-1960-2019 · Reported July 24, 2019

    Enforcement

    Recall Number
    Z-1960-2019
    Event ID
    83099
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2019
    Initiation Date
    June 10, 2019
    Classification Date
    July 12, 2019
    Termination Date
    September 10, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

    Reason

    Lack of an adequate sterilization validation.

    Code Info

    Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083 2591050 2771027 3231028 MJ54320 MJ54330 MJ54350 MJ54340

    Distribution

    The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.

    Quantity

    92