BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2375-2016 · Initiated July 20, 2016

    Recall

    Recall Number
    Z-2375-2016
    Event Number
    74782
    Firm
    Nobel Biocare Usa Llc
    FEI Number
    1000125598
    Product Code
    DZI
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 20, 2016
    Terminated
    October 17, 2016
    Address
    22715/22725 Savi Ranch Pkwy, Yorba Linda, CA, 92887

    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.

    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: [email protected]. 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.

    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.

    Quantity

    231 kits