CLASS II Device recall · Reported 2 Dec 2020 · FDA Enforcement Report
Geistlich Bio-Oss Pen recalled by Geistlich Pharma North America
Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen 25, distributed nationwide in the US. The recall was initiated on 19 Oct 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0490-2021
- FDA event ID
- 86628
- Recalling firm
- Geistlich Pharma North America, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Oct 2020
- FDA classified
- 25 Nov 2020
- Reported
- 2 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 19 Oct 2020 | Recall initiated by company | |
| 25 Nov 2020 | Classified by FDA | +37 days |
| 2 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115
Where it was distributed
Worldwide distribution - US Nationwide distribution and the country of Japan.
Questions about this recall
Is Geistlich Bio-Oss Pen 25 recalled?
Yes. Geistlich Pharma North America recalled Geistlich Bio-Oss Pen 25 on 19 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0490-2021.
Why was it recalled?
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane
Which lots are affected?
Lots: 81901650, 82000456
Where was it sold?
Worldwide distribution - US Nationwide distribution and the country of Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Geistlich Pharma North America
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Geistlich Bio-Oss Pen recalled by Geistlich Pharma North America | Geistlich Pharma North America | Device Malfunction | Nationwide |
| Device | CLASS II | Geistlich Bio-Oss Pen recalled by Geistlich Pharma North America | Geistlich Pharma North America | Device Malfunction | Nationwide |
| Device | CLASS II | Geistlich Bio-Oss Pen, Sterile cancellous granules recalled | Geistlich Pharma North America | E. coli | Nationwide |
| Device | CLASS II | Geistlich Bio-Oss Pen, Sterile cancellous granules recalled | Geistlich Pharma North America | E. coli | Nationwide |
| Device | CLASS II | Geistlich Bio-Oss Pen, Sterile cancellous granules recalled | Geistlich Pharma North America | E. coli | Nationwide |
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