Recall Z-0840-06 ยท DZE Implant, Endosseous, Root-Form
Straumann Manufacturing Inc.
Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043
| Date | May 4, 2006 (initiated Mar 30, 2006) |
| Status | Terminated |
| Reason | The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top |
| Root cause | Other |
| Action | Straumann USA notified accounts by letter dated 3/30/06 via Federal Express. Accounts are requested to return stock. |
| Quantity | 103 units |
| Distribution | Nationwide. CA, CO, CT, IA, IL, IN, FL, GA, MA , MD, MS, NC, NY, OH, OK, PA, TX, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960634 | TITANIUM HEALING CAPS The Straumann Co., Jun 18, 1996 |