Geistlich Bio-Oss Pen — Class II medical device recall Z-2146-2019
Terminated recall by Geistlich Pharma North America, Inc., reported 2019-08-14, distributed nationwide. When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of t
| Recall number | Z-2146-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Geistlich Pharma North America, Inc., Princeton, NJ, United States |
| Recall initiated | 2019-04-12 |
| Classified | 2019-08-02 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-10-21 |
| Distributed | Nationwide (US) |
| Quantity | 244,268 total |
| Lot numbers | 81600760, 81700194, 81700829, 81800289, 81800863 |
| Model numbers | 20116 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2146-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.