Geistlich Pharma North America, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2146-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 12, 2019

Date Posted: August 14, 2019

Recall Number: Z-2146-2019

Event ID: 82636

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.

Status: Terminated

Product Quantity: 244,268 total

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated