FDA-Device2019-08-14Class II
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.
Geistlich Pharma North America, Inc.
Hazard
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Sold states
US Nationwide distribution.
Affected count
244,268 total
Manufactured in
202 Carnegie Ctr Ste 103, N/A, Princeton, NJ, United States
Products
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2145-2019Don't want to check this manually?
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