Recall Z-0029-05 ยท DZE Implant, Endosseous, Root-Form
Implant Innovations, Inc.
EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
| Date | Oct 21, 2004 (initiated Oct 4, 2004) |
| Status | Terminated |
| Reason | The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted. |
| Root cause | Other |
| Action | Begining on October 4, 2004 each direct account was contacted by email, faxed letter and telephone. They were informed of the recall and instructed to contact their customers if the product had been sold. |
| Quantity | 216 units |
| Distribution | Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East. |
| 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 |