Geistlich Pharma North America, Inc.: When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

Agency Publication Date: August 2, 2019

Affected Products

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.

Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056.

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.

Lots: 81600760, 81700194, 81700829, 81800289, 81800863.

Product: Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - 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.

Lots: 81700464, 81700811, 81800292, 81800866.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82636

Status: Resolved

Manufacturer: Geistlich Pharma North America, Inc.

Manufactured In: United States

Units Affected: 3 products (244,268 total)

Agency Last Updated: August 16, 2019

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Sources: FDA iRES · Raw API Response

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Affected Products

Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056.

Lots: 81600760, 81700194, 81700829, 81800289, 81800863.

Lots: 81700464, 81700811, 81800292, 81800866.