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.
FDA Recall Z-0923-03 · Posted 2003-06-17
Advertisement
Recalling FirmImplant Innovations, Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2003-05-09
Date Terminated2012-05-03
Product Quantity185
Reason for Recall
Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement