BEUDAMED
    FDA Enforcement Class II Terminated

    Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

    Recall: Z-1111-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1111-2019
    Event ID
    82382
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver Visitec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2019
    Initiation Date
    March 12, 2019
    Classification Date
    April 9, 2019
    Termination Date
    August 11, 2020
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

    Reason

    Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device

    Code Info

    Lot Number: 6008554

    Distribution

    Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS

    Quantity

    196 boxes (10units/box)