BEUDAMED
    FDA Enforcement Class II Terminated

    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

    Recall: Z-1931-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1931-2014
    Event ID
    68457
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    May 19, 2014
    Classification Date
    June 27, 2014
    Termination Date
    October 29, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

    Reason

    Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

    Code Info

    Size 1, includes the following Lot numbers: 37217848 61424993 61507222 61543969 61774117 62141262 62193298 62251564 62261955 62383353 62602809 62602810 62602811

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.

    Quantity

    41,180 total