BEUDAMED
    FDA Enforcement Class II Terminated

    Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.

    Recall: Z-2074-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2074-2015
    Event ID
    71552
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nobel Biocare Usa Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    June 22, 2015
    Classification Date
    July 15, 2015
    Termination Date
    September 18, 2015
    Address
    22715/22725 Savi Ranch Pkwy, N/A, Yorba Linda, CA, 92887, United States

    Description

    Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.

    Reason

    One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.

    Code Info

    Article No. 37882, Batch No. 96149; Article No. 37508, Batch No. 814929, 815096, 815140, and 855021.

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, South Africa, Spain, Switzerland, and United Kingdom.

    Quantity

    149 units total