BEUDAMED
    FDA Enforcement Class II Terminated

    Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

    Recall: Z-0906-2015 · Reported January 14, 2015

    Enforcement

    Recall Number
    Z-0906-2015
    Event ID
    69466
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2015
    Initiation Date
    October 9, 2014
    Classification Date
    January 5, 2015
    Termination Date
    June 8, 2016
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

    Reason

    Mislabeled

    Code Info

    Catalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.

    Distribution

    International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.

    Quantity

    96