BEUDAMED
    FDA Enforcement Class II Terminated

    Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248

    Recall: Z-2086-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2086-2016
    Event ID
    74173
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 6, 2016
    Initiation Date
    April 29, 2016
    Classification Date
    June 29, 2016
    Termination Date
    October 19, 2016
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States

    Description

    Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248

    Reason

    As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly. The labeling incorrectly reflects the material as Cobalt Chromium instead of Titanium.

    Code Info

    Cat No. 10207205, Lot: QJ0248

    Distribution

    NC and PA

    Quantity

    12 units