FDA recall Z-2147-2019

Geistlich Pharma North America, Inc. · Class II · device

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.

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.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2019-04-12
Report date
2019-08-14
Termination date
2020-10-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2147-2019