Recall Z-0665-03 ยท DZE Implant, Endosseous, Root-Form
Implant Innovations, Inc.
LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,
| Date | Mar 20, 2003 (initiated Jan 28, 2003) |
| Status | Terminated |
| Reason | Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size. |
| Root cause | Other |
| Action | The firm faxed a recall notification to their accounts on 1/28/2003. Consignees were requested to subrecall to the user/health professional level and respond. Also they were requested to provide disposition information. |
| Quantity | 68 |
| Distribution | Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950204 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM) Implant Innovations, Inc., Sep 27, 1995 |