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U.S. Department of Health and Human Services

Class 2 Device Recall OsseoFix Drill

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  Class 2 Device Recall OsseoFix Drill see related information
Date Initiated by Firm May 09, 2003
Date Posted June 17, 2003
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-0923-03
Recall Event ID 26370
510(K)Number K736396  
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
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.
Code Information lot numbers 126509, 183758, 186315, 188528, 187918, 188867, 190033, 191429, 196769.
Recalling Firm/
Manufacturer		 Implant Innovations, Inc.
4555 Riverside Dr
Palm Beach Gardens FL 33410
For Additional Information Contact Jacquelyn Hughes
800-443-8166
Manufacturer Reason
for Recall		 Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.
FDA Determined
Cause 2		 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 in Commerce 185
Distribution Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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