BEUDAMED
    FDA Recall Completed

    Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.

    Recall: Z-0708-2020 · Initiated January 31, 2019

    Recall

    Recall Number
    Z-0708-2020
    Event Number
    84126
    Firm
    RHONDIUM LIMITED
    FEI Number
    3011789026
    Product Code
    EBF
    Status
    Completed
    Root Cause
    Employee error
    Initiated
    January 31, 2019
    Address
    4 Sheffield Street, Katikati, New Zealand

    Description

    Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.

    Reason

    The product was mislabeled with an incorrect expiration date.

    Action

    The firm called and emailed their U.S. customers on 1/31/2019 to notify them the device was labeled with the incorrect expiration date and was actually expiring that day.

    Distribution

    Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.

    Quantity

    6 devices