BEUDAMED
    FDA Enforcement Class II Terminated

    COMP PRIMARY STEM 8MM MINI, model # 113628

    Recall: Z-0299-2018 · Reported January 10, 2018

    Enforcement

    Recall Number
    Z-0299-2018
    Event ID
    78167
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 10, 2018
    Initiation Date
    June 5, 2017
    Classification Date
    December 29, 2017
    Termination Date
    March 6, 2018
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    COMP PRIMARY STEM 8MM MINI, model # 113628

    Reason

    Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

    Code Info

    Lot Number: 523080

    Distribution

    Nationwide in US; Internationally Argentina, Netherlands & Canada

    Quantity

    N/A