FDA Device recall Z-2145-2019
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usag…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usag… by Geistlich Pharma North America, citing when unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2145-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-12 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Geistlich Pharma North America |
| Distribution | US |
Product
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - 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
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Identifiers
| code_info | Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2145-2019%22
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