Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen, Sterile cancellous granules in an app
Recalled Product
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - 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.
Hazard / Issue
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Issued by
FDA
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