BEUDAMED
    FDA Enforcement Class II Terminated

    NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

    Recall: Z-0658-2022 · Reported March 2, 2022

    Enforcement

    Recall Number
    Z-0658-2022
    Event ID
    89465
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nobel Biocare Usa Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2022
    Initiation Date
    December 17, 2021
    Classification Date
    February 18, 2022
    Termination Date
    October 25, 2024
    Address
    22715 Savi Ranch Pkwy, Yorba Linda, CA, 92887-4609, United States

    Description

    NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

    Reason

    Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.

    Code Info

    Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.

    Quantity

    702 pieces