Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc.
FDA device recall Z-0923-03 · posted 2003-06-17 · Terminated
Recall details
- Recalling firm
- Implant Innovations, Inc.
- Reason for recall
- Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 185
- Distribution
- Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.
- Date initiated
- 2003-05-09
- Date posted
- 2003-06-17
- Date terminated
- 2012-05-03
- Location
- Palm Beach Gardens, FL
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