Z-0490-2021Class II

Geistlich Bio-Oss Pen 0.25-1mm 0.25g -

Name: Z-0490-2021 Geistlich Bio-Oss Pen 0.25-1mm 0.25g -
Creator: Geistlich Pharma North America, Inc.
Published: 2020-10-19
License: https://open.fda.gov/license/

Geistlich Pharma North America, Inc / initiated 2020-10-19 / Terminated / root cause: design

FDA source

Geistlich Pharma North America, Inc. began a recall of Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and... on 2020-10-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0490-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-19
Posted: 2020-11-25
Terminated: 2021-07-13
Recalling firm: Geistlich Pharma North America, Inc
Product: 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
Product code: NPM Bone Grafting Material, Animal Source
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
Root cause tag: design
FDA root cause: Device Design
Action: Geistlich Pharma North America, Inc. issued Urgent Medical Device Notification letter on 10/19/20 stating reason for recall, health risk and action to take: Action Requested of Customer 1. Please complete the Acknowledgement and Receipt Form even if you do not have affected product on hand. 2. If you still have inventory of Geistlich Bio-Oss Pen with the impacted lot numbers, please immediately discontinue use and return all affected product together with the completed response form. A customer care representative will contact you to coordinate your refund and/or a replacement of goods. 3. If you have experienced this issue and have not reported this to date, please contact Geistlich Pharma North America, Inc. 4. If the product has been further distributed to other customers, please forward this notice and report to Geistlich Pharma North America. We apologize for this inconvenience and appreciate your attention to this matter. If you have any questions, please contact us at 855-799-5500 or [email protected]
Quantity in commerce: 1759 units
Distribution: Worldwide distribution - US Nationwide distribution and the country of Japan.
Product codes and lots: Lots: 81901650, 82000456

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0490-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0490-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25
Z-0491-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25
Z-0492-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25

Product code NPM

K120601Class IIGeistlich Bio-Oss Pen (0.25 G, 0.25-1.0Mm Granules), Geistlich Bio-Oss Pen (0.5 G, 0.25-1.0Mm Granules), Geistlich Bio-OGeistlich Pharma AG / cleared 2012-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)