Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-10-17 | Z-0582-2026 | Class II | Open, Classified | The possibility for this product that is intended for demonstration purposes only to be placed in patients.Distribution: US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA. | 61 units | clearance family |
| 2018-03-23 | Z-1694-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.Distribution: Distributed US Nationwide and Puerto Rico. | 3046 | clearance family |
| 2018-03-23 | Z-1695-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.Distribution: Distributed US Nationwide and Puerto Rico. | 2816 | clearance family |
| 2018-03-23 | Z-1693-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.Distribution: Distributed US Nationwide and Puerto Rico. | 2381 | clearance family |
| 2018-03-23 | Z-1697-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.Distribution: Distributed US Nationwide and Puerto Rico. | 2356 | clearance family |
| 2018-03-23 | Z-1698-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.Distribution: Distributed US Nationwide and Puerto Rico. | 1084 | clearance family |
| 2018-03-23 | Z-1696-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.Distribution: Distributed US Nationwide and Puerto Rico. | 2915 | clearance family |
Regulatory clearances
- PMAP93002130-day notice accepted (OK30) · 2025-09-05 · +19 earlier decisionsclearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2018-08-30 | VAI | Voluntary action indicated | Straumann Manufacturing, Inc | 2 |
| 2017-12-07 | VAI | Voluntary action indicated | Jjgc Industria E Comercio De Materials Dentarios Sa | 4 |
| 2017-07-21 | VAI | Voluntary action indicated | Straumann USA LLC | 6 |
| 2016-06-02 | OAI | Official action indicated | ANTHOGYR SAS | 5 |
| 2014-11-13 | NAI | No action indicated | Straumann USA LLC | 0 |
| 2014-11-13 | NAI | No action indicated | Straumann USA LLC | 0 |
| 2014-09-03 | NAI | No action indicated | Biora AB | 0 |
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