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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LCJ
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