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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Implant Innovations, Inc.
Lot Codes / Batch Numbers
lot numbers 126509, 183758, 186315, 188528, 187918, 188867, 190033, 191429, 196769.
Products Sold
lot numbers 126509, 183758, 186315, 188528, 187918, 188867, 190033, 191429, 196769.
Implant Innovations, Inc. is recalling Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Impla due to Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026