Recall Z-0300-05 ยท NDP Accessories, Implant, Dental, Endosseous
The Straumann Company
Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084
| Date | Dec 9, 2004 (initiated Nov 11, 2004) |
| Status | Terminated |
| Reason | Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN) |
| Root cause | Other |
| Action | Straumann USA notified users by letter dated 11/11/04 via overnight mail advising users of the label error. |
| Quantity | 85 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.