BEUDAMED
    FDA Enforcement Class II Ongoing

    Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

    Recall: Z-0518-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0518-2024
    Event ID
    93390
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Riverpoint Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2023
    Initiation Date
    October 25, 2023
    Classification Date
    December 8, 2023
    Address
    825 NE 25th Ave, N/A, Portland, OR, 97232-2304, United States

    Description

    Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

    Reason

    Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.

    Code Info

    Product Code: 3911-7 14-520 UDI-DI Code: 00840277402172 Lot Number: 23080433 Product Code: 3911-7 14-521 UDI-DI Code: 00840277402189 Lot Number: 23081617

    Distribution

    U.S. Nationwide distribution in the state of CA.

    Quantity

    999 devices