Events

Recall of Device Recall Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit

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
    74782
  • Event Risk Class
    Class 2
  • Event Number
    Z-2375-2016
  • Event Initiated Date
    2016-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148438
  • 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
    Drill, bone, powered - Product Code DZI
  • Reason
    Incorrect drill protocol in the instructions for use (ifu).
  • Action
    The firm, Nobel Biocare, sent "IMPORTANT-QUALITY MESSAGE" Field Correction Letters and response forms dated July 22, 2016. The letter describes the product, problem and actions to be taken and informs the customers that the titles of the IFU and the Manual are "NobelGuide for NobelParallel Conical Connection" (ID number 2002) and "Guided Surgery with Nobel Parallel Conical Connection" (ID number 79423). The Customers are instructed to review if you have a printed version of the IFU or the Manual related to the article and discard them; and to complete the attached "Quality Message Acknowledgement" form and fax to 714-998-9348 or email to: joann.radovich@nobelbiocare.com. Customers are informed that an English version of the corrected IFU is attached to the letter and translated versions will be available on the Nobel Biocare website for electronic IFU's http://www.nobelbiocare.com/IFU within 30 days. If you have further questions, contact our customer service department at 714-322-5001.

Device

Device Recall Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit
  • Model / Serial
    Article 38072-all lots
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.
  • Product Description
    Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit || Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. || The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
  • 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