Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 2…

Recall date

April 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2146-2019

FDA classification

Class II

Brand / firm

Geistlich Pharma North America, Inc.

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.