Recall Z-0975-05 ยท DZE Implant, Endosseous, Root-Form
Straumann Manufacturing Inc
RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
| Date | Jul 7, 2005 (initiated Jun 6, 2005) |
| Status | Terminated |
| Reason | Basal screw is too short to adequately hold the dental abutment in the implant |
| Root cause | Other |
| Action | Straumann USA initiated the recall by letter dated 6/6/05. Users are requested to return devices and to examine patients with the implanted device. |
| Quantity | 23 |
| Distribution | AZ, CA, DE, FL, NY, OH, OK, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020096 | ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM Institut Straumann AG, Feb 8, 2002 |