BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

    Recall: Z-1550-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1550-2026
    Event ID
    98353
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medartis AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2026
    Initiation Date
    January 9, 2026
    Classification Date
    March 10, 2026
    Address
    Hochbergerstrasse 60e, N/A, Basel Town, N/A, N/A, Switzerland

    Description

    Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

    Reason

    Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

    Code Info

    Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933

    Distribution

    Worldwide - US Nationwide distribution in the states of Indiana and Pennsylvania and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, and Poland.

    Quantity

    126