Recall Z-0922-2007 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i
EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
| Date | Jun 14, 2007 (initiated Oct 16, 2006) |
| Status | Terminated |
| Reason | Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed. |
| Root cause | Other |
| Action | Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm. |
| Distribution | Worldwide. |
| 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 |