Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 2, 2020
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Geistlich Pharma North America, Inc. recalled Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bon… - a moderate-severity action.
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bon… was recalled by Geistlich Pharma North America, Inc. in December 2, 2020. Reason: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules …. Check the official notice for the remedy. Verify recall #Z-0492-2021 with the FDA Devices before acting.
The recall
Geistlich Pharma North America, Inc. issued this moderate-severity FDA Devices recall-Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules ….
- Moderate
- severity level
- 537 units
- affected scope
- Class II
- classification
- December 2, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0492-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0492-2021) was formally reported on December 2, 2020, with the manufacturer initiating the action on October 19, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Geistlich Pharma North America, Inc. is listed as the recalling firm, operating out of Princeton, NJ. Federal records list the affected scope as 537 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the country of Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
537 units
Related Recalls
6
3 from same agency
Product description
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0492-2021 |
| Date reported | December 2, 2020 |
| Date initiated | October 19, 2020 |
| Recalling firm | Geistlich Pharma North America, Inc. |
| Firm location | Princeton, NJ |
| Affected scope | 537 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Japan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0492-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126. Recalled by Geistlich Pharma North America, Inc.. Units affected: 537 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2020. Severity: Moderate. Recall number: Z-0492-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution and the country of Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0492-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 2, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.