Recall Z-0811-2007 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i
Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.
| Date | May 16, 2007 (initiated Apr 25, 2007) |
| Status | Terminated |
| Reason | The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant. |
| Root cause | Other |
| Action | Each consignee was notified on 4/25/2007 by telephone using a prepared script. A follow letter was sent by fax. Each consignee was instructed to check their respective inventory for the affected product and to return a response card and any affected product to the firm. |
| Quantity | 362 units |
| Distribution | Distributed worldwide, including USA, Spain and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934126 | ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS Implant Innovations, Inc., Apr 25, 1994 |