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U.S. Department of Health and Human Services

Class 2 Device Recall Tissue expander

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  Class 2 Device Recall Tissue expander see related information
Date Initiated by Firm August 09, 2016
Date Posted September 07, 2016
Recall Status1 Terminated 3 on March 08, 2017
Recall Number Z-2747-2016
Recall Event ID 74895
510(K)Number K130813  
Product Classification Expander, skin, inflatable - Product Code LCJ
Product MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312

The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
Code Information Lot 6981537
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		 Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
FDA Determined
Cause 2		 Employee error
Action The firm, Mentor, sent an "MEDICAL DEVICE REMOVAL" letter dated 8/11/2016 to affected consignees. The letter will be followed up with a respective sales representative visit. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately identify all unused units and return them per the normal return process; forward the letter to anyone your facility that needs to be informed; if you have sent these units to another facility, forward the letter to that facility; and maintain awareness of the letter until all units in your inventory have been returned. If you have any questions, please contact your local Mentor sales representative or Mentor Customer Service at 1-800-235-5731.
Quantity in Commerce 65 units
Distribution Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
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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