BEUDAMED
    FDA Enforcement Class II Ongoing

    Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

    Recall: Z-2361-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2361-2026
    Event ID
    98952
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medartis AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2026
    Initiation Date
    April 24, 2026
    Classification Date
    June 9, 2026
    Address
    Hochbergerstrasse 60e, N/A, Basel Town, N/A, N/A, Switzerland

    Description

    Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

    Reason

    The cannulation of the CCS screw is not centered.

    Code Info

    UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997

    Distribution

    US Nationwide distribution in the states of LA, TX. IN, CA, NC.

    Quantity

    13 units