BEUDAMED
    FDA Enforcement Class II Terminated

    NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: 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-1851-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1851-2020
    Event ID
    85236
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nobel Biocare Usa Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2020
    Initiation Date
    August 28, 2019
    Classification Date
    May 4, 2020
    Termination Date
    April 28, 2021
    Address
    22715 Savi Ranch Pkwy, N/A, Yorba Linda, CA, 92887-4609, United States

    Description

    NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: 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

    The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).

    Code Info

    Lot:12129104

    Distribution

    International distribution - the country Russia only.

    Quantity

    228 pieces