Home / Recalls / Geistlich Pharma North America, Inc. / Z-2147-2019

Z-2147-2019 Class II Terminated

Recalled by Geistlich Pharma North America, Inc. — Princeton, NJ

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
April 12, 2019
Termination Date
October 21, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
244,268 total

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.

Distribution Pattern

US Nationwide distribution.

Code Information

Lots: 81700464, 81700811, 81800292, 81800866.

Other recalls by Geistlich Pharma North America, Inc.

  • Z-0491-2021 Class II — Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for fi (October 19, 2020)
  • Z-0492-2021 Class II — Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filli (October 19, 2020)
  • Z-0490-2021 Class II — Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for f (October 19, 2020)
  • Z-2146-2019 Class II — Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0 (April 12, 2019)
  • Z-2145-2019 Class II — Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0 (April 12, 2019)