PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 14, 2019 Initiated: April 12, 2019 #Z-2147-2019

Product Description

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.

Reason for Recall

When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

Details

Units Affected
244,268 total
Distribution
US Nationwide distribution.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Geistlich Pharma North America, Inc.. Units affected: 244,268 total.
Why was this product recalled? ▼
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2147-2019.

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