BEUDAMED
    FDA Enforcement Class II Ongoing

    LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

    Recall: Z-2425-2020 · Reported July 1, 2020

    Enforcement

    Recall Number
    Z-2425-2020
    Event ID
    85369
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zest Anchors LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 1, 2020
    Initiation Date
    November 22, 2019
    Classification Date
    June 23, 2020
    Address
    2875 Loker Ave E, N/A, Carlsbad, CA, 92010-6626, United States

    Description

    LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

    Reason

    The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.

    Code Info

    The UDI number for the affected lots are as follows: Product Name Part # LOCATOR Overdenture Implant, 2.4mmD x 12mmL,2.5mm Cuff 07451 Lot # L17MB; UDI Number: 00840481101496 LOCATOR Overdenture Implant, 2.4mmD x 12mmL, 4mm Cuff 07456 Lot # Ll5PB; L166F; UDI Number: 00840481101526 LOCATOR Overdenture Implant, 2.9mmD x 10mmL, 4mm Cuff 07465 Lot # L15H7; L15H9; UDI Number: 00840481101571 LOCATOR Overdenture Implant, 2.9mmD x 14mmL, 4mm Cuff 07467 Lot # USHA UDI Number: 00840481101595 LOCATOR Overdenture Implant, 3.4mmD x 12mmL, 4mm Cuff 07476 Lot # L17VE; UDI Number: 00840481126116

    Distribution

    US Nationwide Distribution in the state of: WI; VA; OH; IL; GA; NC; KS; NJ; CA; WA; OK; MO and Puerto Rico OUS: Switzerland, Germany, Mexico, Poland, and Thailand

    Quantity

    154 kits