Recall Z-0924-03 ยท DZE Implant, Endosseous, Root-Form
Implant Innovations, Inc.
Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)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 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 | 15 |
| 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.