BEUDAMED
    FDA Enforcement Class II Terminated

    The 2nd Assist Knee Positioner

    Recall: Z-0803-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0803-2018
    Event ID
    79141
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    September 7, 2017
    Classification Date
    February 28, 2018
    Termination Date
    August 23, 2018
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    The 2nd Assist Knee Positioner

    Reason

    Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.

    Code Info

    Item# 740026

    Distribution

    Nationally

    Quantity

    38,879 units