Geistlich Pharma North America, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0491-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 19, 2020

Date Posted: December 2, 2020

Recall Number: Z-0491-2021

Event ID: 86628

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

Status: Terminated

Product Quantity: 2097 units

Code Information:

Lots: 81901649, 82000457, 82000633

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated