BEUDAMED
    FDA Enforcement Class II Ongoing

    Smart Toe II Intramedullary Arthrodesis Implant

    Recall: Z-1011-2022 · Reported May 4, 2022

    Enforcement

    Recall Number
    Z-1011-2022
    Event ID
    89861
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2022
    Initiation Date
    March 28, 2022
    Classification Date
    April 27, 2022
    Address
    Bohnackerweg 1, Selzach, N/A, Switzerland

    Description

    Smart Toe II Intramedullary Arthrodesis Implant

    Reason

    The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".

    Code Info

    Model Number ST0XS-13; UDI: 07613252263470; Lot Code (Expiration Date): H52262 (08/31/2026) Model Number ST0-19P; UDI: 07613252263340; Lot Code (Expiration Date): H54191 (08/31/2026) Model Number ST0A-16P; UDI: 07613252263418; Lot Code (Expiration Date): H54193 (09/30/2026) Model Number ST0XS-11; UDI: 07613252263456; Lot Code (Expiration Date): H55690 (09/30/2026) Model Number ST0-22P; UDI: 07613252263388; Lot Code (Expiration Date): H56502 (09/30/2026)

    Distribution

    Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    246 implants