Recall Z-0923-03 ยท DZE Implant, Endosseous, Root-Form
Implant Innovations, Inc.
Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.
| Date | Jun 17, 2003 (initiated May 9, 2003) |
| Status | Terminated |
| Reason | Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills. |
| Root cause | Other |
| Action | The firm faxed and e-mailed a recall communication to international accounts on 5/9/2003 and mailed recall letters to domestic accounts on 5/12/2003. The firms were requested to examine their stock and return product as well as to notify any subaccounts of the recall and recover and return their products. Letters to specific consignees only listed the recalled lot numbers that were shipped to that consignee. A response form was included and was to be faxed back to the recalling firm. |
| Quantity | 185 |
| Distribution | Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.