Home / Recalls / Geistlich Pharma North America, Inc. / Z-0490-2021

Z-0490-2021 Class II Terminated

Recalled by Geistlich Pharma North America, Inc. — Princeton, NJ

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
1759 units

Product Description

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

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: 81901650, 82000456

Other recalls by Geistlich Pharma North America, Inc.

  • Z-0491-2021 Class II — Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for fi (October 19, 2020)
  • Z-0492-2021 Class II — Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filli (October 19, 2020)
  • Z-2146-2019 Class II — Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0 (April 12, 2019)
  • Z-2145-2019 Class II — Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0 (April 12, 2019)
  • Z-2147-2019 Class II — Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, (April 12, 2019)