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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 3isee related information
Date Initiated by FirmDecember 02, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 05, 2009
Recall NumberZ-0385-04
Recall Event ID 28092
Product Classification Drill, Bone, Powered - Product Code DZI
ProductProducts 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 DT220 2.3mm (D) x 20.0 mm (L) STERILE.
Code Information 219636
Recalling Firm/
Manufacturer		 Implant Innovations, Inc.
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information ContactJacquelyn A. Hughes
800-443-8166
Manufacturer Reason
for Recall		The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce16
DistributionProduct 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 CycleTPLC 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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