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/ Manufacturer |
Implant Innovations, Inc. 4555 Riverside Dr Palm Beach Gardens FL 33410
|
For Additional Information Contact |
Jacquelyn A. Hughes, RAC 800-443-8166
|
Manufacturer Reason for Recall |
Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
|
FDA Determined Cause 2 |
Other |
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.
|