BEUDAMED
    FDA Enforcement Class II Terminated

    Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    Recall: Z-2417-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2417-2019
    Event ID
    83423
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2019
    Initiation Date
    July 25, 2019
    Classification Date
    August 27, 2019
    Termination Date
    September 24, 2020
    Address
    Bohnackerweg 1, N/A, Selzach, N/A, N/A, Switzerland

    Description

    Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    Reason

    The seal integrity of the sterile bag containing the kits may be compromised.

    Code Info

    Lot Numbers 01398, 01465, 01481

    Distribution

    US Nationwide Distribution

    Quantity

    1533