Recall Z-1035-04 ยท DZE Implant, Endosseous, Root-Form
The Straumann Company
Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088
| Date | Jul 20, 2004 (initiated May 21, 2004) |
| Status | Terminated |
| Reason | Outside label incorrectly identifies drill as Wide Neck (WN) instead of Regular Neck (RN) |
| Root cause | Other |
| Action | Straumann notifed conisignees by letter on May 21,2004 via Fed''X overnight advising of the error on the label states WN instead of RN. The user is advised to that the ID on the article is incorrect. |
| Quantity | 23 units |
| Distribution | Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.