BEUDAMED
    FDA Enforcement Class II Ongoing

    BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:110045154

    Recall: Z-2060-2023 · Reported July 12, 2023

    Enforcement

    Recall Number
    Z-2060-2023
    Event ID
    92410
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 12, 2023
    Initiation Date
    May 4, 2023
    Classification Date
    July 3, 2023
    Address
    Kibbutz Gatton, N/A, GAATON, N/A, N/A, Israel

    Description

    BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:110045154

    Reason

    Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

    Code Info

    UDI-DI: 0818674025765 Lot Numbers: 21R01, 21R02, 21R03, 22C02, 22C03, 22C06, 22C08, 22E01, 22E02, 22F01, 22F02, 22F03, 22J01, 22J02, 22J03, 22K01, 22K02, 22K03, 22K04, 22K05, 22K07, 22K08, 22K09, 22K10, 22K11, 22M01, 22M02, 22M03, 22M04, 22N01, 22P01, 22P02, 22P03, 22P04, 22P05, 22R01

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.

    Quantity

    N/A