Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Tissue expander

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Tissue expandersee related information
Date Initiated by FirmAugust 09, 2016
Date PostedSeptember 07, 2016
Recall Status1 Terminated 3 on March 08, 2017
Recall NumberZ-2747-2016
Recall Event ID 74895
510(K)NumberK130813 
Product Classification Expander, skin, inflatable - Product Code LCJ
ProductMENTOR 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 ContactCustomer 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
ActionThe 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 Commerce65 units
DistributionWorldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LCJ
-
-