BEUDAMED
    FDA Enforcement Class II Terminated

    Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.

    Recall: Z-0413-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0413-2018
    Event ID
    78861
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    December 27, 2017
    Classification Date
    January 26, 2018
    Termination Date
    April 29, 2024
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339, United States

    Description

    Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.

    Reason

    Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).

    Code Info

    Part Number for Elements Obturation Unit (EOU): 973-0322; and Part Numbers for the Buchanan Heat Pluggers: 952-0004, 952-0003, 952-0005, 952-0006, 952-0007, 952-0031, 973-0219 (hot pulp test tip). All serial numbers of the EOU and respective Buchanan Heat Pluggers are included in the recall.

    Distribution

    USA (nationwide) distributed to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Armenia, Australia, Canada, Chile, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Malaysia, Mexico, Netherlands, Pakistan, Panama, Philippines, Singapore, South Korea, Switzerland, Thailand, United Kingdom, Vietnam.

    Quantity

    25,765 total