BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1821-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1821-2024
    Event ID
    94445
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medartis Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 22, 2024
    Initiation Date
    April 12, 2024
    Classification Date
    May 14, 2024
    Address
    1195 Polk Dr, N/A, Warsaw, IN, 46582-8602, United States

    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.

    Code Info

    Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.

    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