BEUDAMED
    FDA Enforcement Class II Ongoing

    Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

    Recall: Z-1321-2024 · Reported March 27, 2024

    Enforcement

    Recall Number
    Z-1321-2024
    Event ID
    94032
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Preat Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2024
    Initiation Date
    February 9, 2024
    Classification Date
    March 20, 2024
    Address
    2625 Skyway Dr Ste B, Santa Maria, CA, 93455-1405, United States

    Description

    Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

    Reason

    Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.

    Code Info

    Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489

    Distribution

    U.S. Nationwide distribution in the states of AZ, OH and PA.

    Quantity

    561 units