BEUDAMED
    FDA Enforcement Class II Terminated

    Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

    Recall: Z-2557-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2557-2017
    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

    Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- 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:00225248015, Lot Number Expiry Date Before: March 2027

    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

    N/A