BEUDAMED
    FDA Enforcement Class II Terminated

    DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.

    Recall: Z-1436-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1436-2021
    Event ID
    87684
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Leibinger GmbH & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 28, 2021
    Initiation Date
    April 1, 2021
    Classification Date
    April 19, 2021
    Termination Date
    December 19, 2022
    Address
    Botzinger Str. 41, N/A, Freiburg Im Breisgau, N/A, N/A, Germany

    Description

    DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.

    Reason

    Inability for the user to inject the paste from the syringe into the target location.

    Code Info

    Lot: DI20311,DI20307 Product Code (UDI): 07613327123265

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.

    Quantity

    321 units