BEUDAMED
    FDA Recall Open, Classified

    APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

    Recall: Z-1821-2024 · Initiated April 12, 2024

    Recall

    Recall Number
    Z-1821-2024
    Event Number
    94445
    Firm
    Medartis Inc.
    FEI Number
    3009540749
    Product Code
    HWC
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 12, 2024
    Posted
    May 14, 2024
    Address
    1195 Polk Dr, Warsaw, IN, 46582-8602

    Description

    APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

    Reason

    Screw is 16mm long instead of 22mm long.

    Action

    Consignees were sent an "URGENT: Field Safety Notice" via email and printed letter, dated 4/12/2024, notifying them of this recall event. Consignees are asked to locate and quarantine affected devices, coordinate the return of affected devices to their distributor, inform all users of the device of this recall event, and return the provided Customer Reply form with the relevant information. Customers with any questions can call Medartis at 574-241-6531 between 7:30 AM and 6:30 PM EST, Monday through Friday. Questions can also be sent via email to [email protected].

    Distribution

    Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.

    Quantity

    110 units