BEUDAMED
    FDA Enforcement Class II Terminated

    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

    Recall: Z-2828-2020 · Reported August 26, 2020

    Enforcement

    Recall Number
    Z-2828-2020
    Event ID
    86085
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NOBEL BIOCARE SERVICES AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2020
    Initiation Date
    July 20, 2020
    Classification Date
    August 20, 2020
    Termination Date
    May 12, 2021
    Address
    Balz-zimmermannstrasse 7, N/A, Kloten, N/A, N/A, Switzerland

    Description

    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

    Reason

    Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.

    Code Info

    Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.

    Quantity

    188