BEUDAMED
    FDA Enforcement Class II Ongoing

    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    Recall: Z-1234-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1234-2023
    Event ID
    91479
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Leibinger GmbH & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 15, 2023
    Initiation Date
    December 6, 2022
    Classification Date
    March 7, 2023
    Address
    Botzinger Str. 41, Freiburg Im Breisgau, N/A, Germany

    Description

    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    Reason

    Device was shipped without having regulatory approval.

    Code Info

    TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0

    Distribution

    Distribution of one unit only to a single customer in MA (USA)

    Quantity

    1 unit