Recall Z-1086-2007 ยท DZE Implant, Endosseous, Root-Form
Thommen Medical, AG
SPI EASY Abutment. Endosseous dental implant abutment.
| Date | Jul 24, 2007 (initiated Apr 19, 2007) |
| Status | Terminated |
| Reason | The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm. |
| Root cause | Other |
| Action | Letter 5/14/2007. Customers are requested to check their current inventory for the recall product. If found they are to return the product for replacement. If they have implanted the product they are to check patient x-rays for the defect. If defects are found they are to do a restoration. |
| Quantity | 84 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023645 | SPI EASY DENTAL IMPLANT ABUTMENT Thommen Medical AG, Nov 13, 2002 |