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U.S. Department of Health and Human Services

Class 2 Device Recall LTX XP Miniplant

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  Class 2 Device Recall LTX XP Miniplant see related information
Date Initiated by Firm August 03, 2007
Date Posted September 18, 2007
Recall Status1 Terminated 3 on September 11, 2009
Recall Number Z-1221-2007
Recall Event ID 38983
510(K)Number K950204  K063286  
Product Classification Dental Implant - Product Code DZE
Product Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.
Code Information Model No. LTX3211 - Packaged Lot No. 606199 Model No. LTX3213 - Packaged Lot No. 606191
Recalling Firm/
Manufacturer		 Biomet 3i
4555 Riverside Drive
Palm Beach Gardens FL 33410-4200
For Additional Information Contact
561-776-6700 Ext. 6819
Manufacturer Reason
for Recall		 The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.
FDA Determined
Cause 2		 Labeling mix-ups
Action International customers were contacted first by e-mail , then by fax letter 08/03/2007.
Quantity in Commerce 240 (120 each model / lot)
Distribution Product was not distributed within the U.S. Product was distributed Internationally - Brazil, Argentina, Israel, Mexico, Colombia, Korea, Taiwan, Uruguay, Italy, 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.
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