Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 17, 2025 |
| Reported | December 03, 2025 |
| Recalling firm | Straumann USA LLC |
| Country / region | United States MA |
Hazard
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Affected products
- Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Related recalls
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER