BEUDAMED
    FDA Recall Terminated

    Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126

    Recall: Z-0492-2021 · Initiated October 19, 2020

    Recall

    Recall Number
    Z-0492-2021
    Event Number
    86628
    Firm
    Geistlich Pharma North America, Inc.
    FEI Number
    3009439101
    Product Code
    NPM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 19, 2020
    Terminated
    July 13, 2021
    Address
    202 Carnegie Ctr, Ste 103, Princeton, NJ, 08540-6239

    Description

    Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126

    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

    Action

    Geistlich Pharma North America, Inc. issued Urgent Medical Device Notification letter on 10/19/20 stating reason for recall, health risk and action to take: Action Requested of Customer 1. Please complete the Acknowledgement and Receipt Form even if you do not have affected product on hand. 2. If you still have inventory of Geistlich Bio-Oss Pen with the impacted lot numbers, please immediately discontinue use and return all affected product together with the completed response form. A customer care representative will contact you to coordinate your refund and/or a replacement of goods. 3. If you have experienced this issue and have not reported this to date, please contact Geistlich Pharma North America, Inc. 4. If the product has been further distributed to other customers, please forward this notice and report to Geistlich Pharma North America. We apologize for this inconvenience and appreciate your attention to this matter. If you have any questions, please contact us at 855-799-5500 or [email protected]

    Distribution

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

    Quantity

    537 units