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U.S. Department of Health and Human Services

Class 2 Device Recall 3i

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  Class 2 Device Recall 3i see related information
Date Initiated by Firm December 02, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-0386-04
Recall Event ID 28092
Product Classification Drill, Bone, Powered - Product Code DZI
Product Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE
Code Information 221285
Recalling Firm/
Implant Innovations, Inc.
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Jacquelyn A. Hughes
Manufacturer Reason
for Recall
The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.
FDA Determined
Cause 2
Action The firm notified international distributors on 12/2/2003 via e-mail and also a recall notification letter was faxed to them on 12/2/2003. They were instructed to subrecall to the health professional level. Also on 12/2/2003 all domestic accounts (health practioners) were telephoned and then faxed a recall notification letter. Each account was instructed to check their inventory, respond back by fax and to return recalled product to Implant Innovations Inc.
Quantity in Commerce 40
Distribution Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.
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.