BEUDAMED
    FDA Enforcement Class II Ongoing

    Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.

    Recall: Z-1718-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1718-2019
    Event ID
    82796
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    I.T.S. GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    May 9, 2019
    Classification Date
    June 4, 2019
    Address
    Autal 28, Lasnitzhohe, N/A, Austria

    Description

    Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.

    Reason

    The titanium implant has the wrong article number laser marked on it.

    Code Info

    Model Number: 21206-10; Lot Code: 26/F42778

    Distribution

    Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.

    Quantity

    65 devices