Recall Z-0491-2021 ยท NPM Bone Grafting Material, Animal Source
Geistlich Pharma North America, Inc.
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
| Date | Oct 19, 2020 |
| Status | Terminated |
| 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 |
| Quantity | 2097 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120601 | GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O Geistlich Pharma AG, May 24, 2012 |