Recall Z-0925-05 ยท NDP Accessories, Implant, Dental, Endosseous
BioHorizons Implant Systems Inc
The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm
| Date | Jun 23, 2005 (initiated Jun 3, 2005) |
| Status | Terminated |
| Reason | The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement. |
| Root cause | Other |
| Action | The domestic consignees were contacted by telephone on 06/03/2005 to request the return of the products. The foreign consignee was contacted via telephone and email to request the same action. |
| Quantity | 5 units |
| Distribution | PA, TX, MI, VA and Russia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.