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U.S. Department of Health and Human Services

Class 3 Device Recall 3 i Implant Innovations, Inc.

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  Class 3 Device Recall 3 i Implant Innovations, Inc. see related information
Date Initiated by Firm January 28, 2003
Date Posted March 20, 2003
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-0665-03
Recall Event ID 25722
510(K)Number K950204  
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
Product LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,
Code Information For LTX 611 lot number 150102P For LTX 515 lot number 150100P
Recalling Firm/
Implant Innovations, Inc.
4555 Riverside Dr
Palm Beach Gardens FL 33410
For Additional Information Contact Jacquelyn A. Hughes, RAC
Manufacturer Reason
for Recall
Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
FDA Determined
Cause 2
Action The firm faxed a recall notification to their accounts on 1/28/2003. Consignees were requested to subrecall to the user/health professional level and respond. Also they were requested to provide disposition information.
Quantity in Commerce 68
Distribution Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile.
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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = IMPLANT INNOVATIONS, INC.