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U.S. Department of Health and Human Services

Class 2 Device Recall Artoura Breast Tissue Expander

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  Class 2 Device Recall Artoura Breast Tissue Expander see related information
Date Initiated by Firm August 09, 2016
Date Posted September 10, 2016
Recall Status1 Terminated 3 on March 08, 2017
Recall Number Z-2781-2016
Recall Event ID 74899
510(K)Number K130813  
Product Classification Expander, skin, inflatable - Product Code LCJ
Product CPX4 Breast Tissue Expander 650 cc
:
Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.
Code Information Lot 6947019
Recalling Firm/
Manufacturer		 Mentor Texas, LP.
3025 Skyway Cir N
Irving TX 75038-3524
For Additional Information Contact Customer Service
800-235-5731
Manufacturer Reason
for Recall		 The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
FDA Determined
Cause 2		 Employee error
Action Mentor Texas sent an Urgent Field Safety Notice dated August 11, 2016 to customers.via letter and a follow-up with respective Sales Representative visit. The letter identified the affected product, problems and actions to be taken. Customers were informed the firm will credit/replace returned affected products. For questions contact your Sales Representative .
Quantity in Commerce 30 units
Distribution Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
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 = LCJ and Original Applicant = MENTOR CORP.
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