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U.S. Department of Health and Human Services

Class 2 Device Recall BioOss

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  Class 2 Device Recall BioOss see related information
Date Initiated by Firm October 19, 2020
Create Date November 25, 2020
Recall Status1 Terminated 3 on July 13, 2021
Recall Number Z-0491-2021
Recall Event ID 86628
510(K)Number K120601  
Product Classification Bone grafting material, animal source - Product Code NPM
Product 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
Code Information Lots:  81901649, 82000457, 82000633
Recalling Firm/
Manufacturer		 Geistlich Pharma North America, Inc.
202 Carnegie Ctr Ste 103
Princeton NJ 08540-6239
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 2097 units
Distribution Worldwide distribution - US Nationwide distribution and the country of Japan.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = NPM and Original Applicant = GEISTLICH PHARMA AG
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