BEUDAMED
    FDA Enforcement Class II Terminated

    NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.

    Recall: Z-2115-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2115-2017
    Event ID
    77140
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    April 28, 2017
    Classification Date
    May 18, 2017
    Termination Date
    July 3, 2018
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.

    Reason

    Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.

    Code Info

    Item Number: 00-5988-020-14, Lot Number: 63463357, Description: NexGen Offset Stem Ext Size 14, UDI: (01)00889024221475(17)260930(10)63463357; Item Number: 00-5988-020-17, Lot Number: 63463367, Description: (01)00889024221505(17)260930(10)63463367, Manufactured Date: 9/19/2016, Expiration Date: 9/30/2026

    Distribution

    Worldwide Distribution - US Distribution to the states of: WI, CA, PA, NJ, IN, VA, WA, MN and HI ., and to the countries of : Brazil, Canada, Australia, Netherlands, Germany, Iran and Nigeria. VA/DOD: None

    Quantity

    24