BEUDAMED
    FDA Enforcement Class II Terminated

    MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

    Recall: Z-0715-2022 · Reported March 9, 2022

    Enforcement

    Recall Number
    Z-0715-2022
    Event ID
    89458
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Leibinger GmbH & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 9, 2022
    Initiation Date
    December 29, 2021
    Classification Date
    March 3, 2022
    Termination Date
    December 21, 2023
    Address
    Botzinger Str. 41, Freiburg Im Breisgau, N/A, Germany

    Description

    MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

    Reason

    Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

    Code Info

    UDI: 07613252084334; Lot Number: 3R7YHD

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    74