| Class 2 Device Recall BioOss | |
Date Initiated by Firm | October 19, 2020 |
Create Date | November 25, 2020 |
Recall Status1 |
Terminated 3 on July 13, 2021 |
Recall Number | Z-0492-2021 |
Recall Event ID |
86628 |
510(K)Number | K120601 |
Product Classification |
Bone grafting material, animal source - Product Code NPM
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Product | 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 |
Code Information |
Lots: 81901651,82000466 |
Recalling Firm/ Manufacturer |
Geistlich Pharma North America, Inc. 202 Carnegie Ctr Ste 103 Princeton NJ 08540-6239
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For Additional Information Contact | SAME 202-942-5120 |
Manufacturer Reason for Recall | 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 |
FDA Determined Cause 2 | Device Design |
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 orders@geistlich-na.com |
Quantity in Commerce | 537 units |
Distribution | Worldwide distribution - US Nationwide distribution and the country of Japan. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NPM
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