FDA Medical Device Recalls (openFDA)
Geistlich Pharma North America, Inc.: Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115
- Recall number
- Z-0490-2021
- Recalling firm
- Geistlich Pharma North America, Inc.
- Product
- Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115
- Status
- Terminated
- Initiated
- 2020-10-19
- Posted
- not on file
- Terminated
- 2021-07-13
- 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
- Root cause
- 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
- 1759 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Japan.
- Lot, serial or model codes
- Lots: 81901650, 82000456
- 510(k) numbers
- ["K120601"]
- PMA numbers
- not on file
- Product code
- NPM
- Firm FEI
- 3009439101
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28