BEUDAMED
    FDA Enforcement Class II Terminated

    Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116

    Recall: Z-0491-2021 · Reported December 2, 2020

    Enforcement

    Recall Number
    Z-0491-2021
    Event ID
    86628
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Geistlich Pharma North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 2, 2020
    Initiation Date
    October 19, 2020
    Classification Date
    November 25, 2020
    Termination Date
    July 13, 2021
    Address
    202 Carnegie Ctr Ste 103, N/A, Princeton, NJ, 08540-6239, United States

    Description

    Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116

    Reason

    Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane

    Code Info

    Lots: 81901649, 82000457, 82000633

    Distribution

    Worldwide distribution - US Nationwide distribution and the country of Japan.

    Quantity

    2097 units