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Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 2
Recalled August 14, 2019 · FDA recall Z-2145-2019 · Geistlich Pharma North America
Hazard
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. · FDA Class II
Units
244,268 total
Sold at
US Nationwide distribution.
Description
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Product
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.
Manufacturer(s)
Geistlich Pharma North America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →