Events

Recall of Device Recall Abutment Retrieval Instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nobel Biocare Usa Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71552
  • Event Risk Class
    Class 2
  • Event Number
    Z-2074-2015
  • Event Initiated Date
    2015-06-22
  • Event Date Posted
    2015-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138182
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessories, implant, dental, endosseous - Product Code NDP
  • Reason
    One dimension of the affected instrument is incorrect. therefore this instrument cannot be used to remove the metal adapter as intended.
  • Action
    A customer notification letter dated 6/22/15 will be sent to all customers who purchased the Abutment Retrieval Instrument Zirconia CC RP/WP because an internal investigation showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended. The letter provides the problems identified and the actions to be taken. Customers are instructed to complete the acknowledgement form and return it to their local Nobel Biocare Subsidiary with the affected instrument. Customers with the affected instrument that is a part of a kit, Nobel Biocare Representative will contact them directly. Customers with any remaining questions, are instructed to contact their Nobel Biocare Representative.

Device

Device Recall Abutment Retrieval Instrument
  • Model / Serial
    Article No. 37882, Batch No. 96149; Article No. 37508, Batch No. 814929, 815096, 815140, and 855021.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Nobel Biocare Usa Llc

Manufacturer

Nobel Biocare Usa Llc
  • Manufacturer Address
    Nobel Biocare Usa Llc, 22715/22725 Savi Ranch Pkwy, Yorba Linda CA 92887
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA