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.
FDA Recall Z-2747-2016 · Posted 2016-09-07
Recalling FirmMentor Texas, LP.
Recall StatusTerminated
Product CodeLCJ
Date Initiated2016-08-09
Date Terminated2017-03-08
Product Quantity65 units
Reason for Recall
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Firm 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.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.