BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated January 9, 2026

    Recall

    Recall Number
    Z-1550-2026
    Event Number
    98353
    Firm
    Medartis AG Hochbergerstrasse 60e Basel Town Switzerland
    FEI Number
    3003236702
    Product Code
    HWC
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    January 9, 2026
    Posted
    March 10, 2026

    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.

    Action

    Firm began notifying affected customers on January 13, 2026 via email. Customers were instructed to return impacted products to Medartis Inc.

    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