BEUDAMED
    FDA Enforcement Class II Terminated

    Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

    Recall: Z-0650-2022 · Reported February 23, 2022

    Enforcement

    Recall Number
    Z-0650-2022
    Event ID
    89482
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merete Medical GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 23, 2022
    Initiation Date
    January 18, 2022
    Classification Date
    February 17, 2022
    Termination Date
    February 16, 2023
    Address
    Alt-Lankwitz 102, N/A, Berlin, N/A, N/A, Germany

    Description

    Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

    Reason

    Incorrect marketing label (25 mm) was applied to product size 20 mm.

    Code Info

    Model No. CP20120; Lot No. MS2117816; UDI No. (01)04048266150394(17)260706(10)MS2117816

    Distribution

    Domestic: Illinois; Foreign: Germany.

    Quantity

    26 units