BEUDAMED
    FDA Enforcement Class II Terminated

    Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    Recall: Z-2572-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2572-2017
    Event ID
    76629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2017
    Initiation Date
    February 28, 2017
    Classification Date
    June 14, 2017
    Termination Date
    February 27, 2018
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    Reason

    Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

    Code Info

    Item Number: 00585205416, Lot Number Expiry Date Before: July 2026

    Distribution

    Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand

    Quantity

    9867