BEUDAMED
    FDA Enforcement Class II Terminated

    ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM

    Recall: Z-2672-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2672-2020
    Event ID
    85841
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    U&I CORP.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2020
    Initiation Date
    May 26, 2020
    Classification Date
    July 20, 2020
    Termination Date
    April 5, 2024
    Address
    20 Sandan-Ro 76 Beon-Gil, N/A, Uijeongbu, N/A, N/A, Korea (the Republic of)

    Description

    ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM

    Reason

    6.0x50mm poly-reduction screws were laser etched 6.0x45

    Code Info

    Lot #: 19C12063

    Distribution

    U.S.: AZ

    Quantity

    6