Z-0491-2021 Class II Terminated
FDA device recall Z-0491-2021 was initiated by Geistlich Pharma North America, Inc. on October 19, 2020 and is designated Class II. 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 … The recall status is terminated (terminated July 13, 2021). Affected quantity: 2097 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2020
- Initiation Date
- October 19, 2020
- Termination Date
- July 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2097 units
Product Description
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
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
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the country of Japan.
Code Information
Lots: 81901649, 82000457, 82000633